# SSI Vaccine Trial



## Trevor

Hey guys and gals,

I'm on the list for an SSI Vaccine trial here in Vancouver with Qu Biologics. I know a bit about it but not as much as I'd like.

Has anyone already done this in the first phase or through compassionate care?

Really any advice on trials and whatnot would be fantastic.

Right now they just have me gathering my medical records and whatnot.


Thanks!


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## Jennifer

I don't know much about it personally but there is a thread in the Ask the Experts section about it: http://www.crohnsforum.com/showthread.php?t=43965

This poster talks about their experience (from the thread above): http://www.crohnsforum.com/showpost.php?p=657979&postcount=59

Hope it works for you and please keep us posted.


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## rollinstone

Hey trev, I think you're the first and maybe only user of the forum that's gonna be doing the trial which is awesome that we have someone of our own to report back! Tyler (the guy who has had the sustained 3+ year remission) has posted on here before and said the vaccine was like a miracle cure for him. I am really excited for this treatment I think it holds so much promise. Please let us know how you go!


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## Brenden

Good luck in the trial!


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## Trevor

Thanks for the info and support!

Ill do my best to report back with the low down as I go through the process


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## Trevor

Welp, looks like I am in. Passed my blood tests (passed as in did poorly enough to be eligible).

So far I've had to fill out a bunch of forms, give them my medical records and then do a pretty good battery of blood/stool/urine tests.

Next up is an in-person exam with the head trial Doc on March 7th, mostly a formality it sounds like. Oh and I have to fill out sort sort of diary starting next week.

It's been the worst 3-4 months of my life thanks to this whole Crohn's thing (narrowly beating out my last big flare for top honors) so I am really, really hoping they're on to something with this SSI thing, for everyone's sake.

I'll probably be posting more updates as things progress. If anyone has questions I'll do my best to answer them


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## rollinstone

Good luck bro. I think they're onto something, may it fix you right up! Keep us posted as you go please.


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## Trevor

Thanks! I'll post the crohnie updates here and the muggle (ha) updates on my blog. There are some things regular people just can't handle.


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## ronroush7

Wish you the best!

 2


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## Trevor

Nothing new to report so far this week. I have to start filling out the journal on Friday. Not that it will be super exciting, but presumably it's an important part of the process.

I did start a couple of new supplements that are suppose to be immune boosting. I know this is the opposite of what the accepted wisdom is for Crohn's and a couple of them actually warn against use for AI conditions but I figure if I am going to go for this I had better buy in 100%.


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## VeganOstomy

Trevor said:


> Nothing new to report so far this week. I have to start filling out the journal on Friday. Not that it will be super exciting, but presumably it's an important part of the process.
> 
> I did start a couple of new supplements that are suppose to be immune boosting. I know this is the opposite of what the accepted wisdom is for Crohn's and a couple of them actually warn against use for AI conditions but I figure if I am going to go for this I had better buy in 100%.


I'm looking forward to hearing how the SSI vaccine works for you!  I was ready to travel to B.C to do the trial, but I was excluded due to a pending surgery. 

Are the supplements part of the trial?  I've been in a trial before and it's super important that you let the study team know that you're going on something "new"... you don't want anything interfering with the data they are collecting. 

Good luck!


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## rollinstone

Go for it bro, the auto immune theory behind crohns is so dated and flawed. Lookin forward to hearing of your success!


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## bigtruck

Good luck keep us posted


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## F.u.Crohns

Yup good luck and keep us update!


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## Trevor

Well I've just returned from their office! It's across the hall from my GI's office. Talk about convenient.

I'm in for realzie  !!! First injection is on Monday and then it's 4 months of self-injections every other day.

All the well wishes much appreciated.


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## VeganOstomy

Trevor said:


> Well I've just returned from their office! It's across the hall from my GI's office. Talk about convenient.
> 
> I'm in for realzie  !!! First injection is on Monday and then it's 4 months of self-injections every other day.
> 
> All the well wishes much appreciated.


Awesome sauce! Please share your progress if allowed by your non-disclosure agreement. :cool2:


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## Trevor

I'll ask them on Monday what I am allowed to share but they haven't mentioned anything and there was no NDA signed so I think we're good!

So far all I have to report is comfy chairs and cheap toilet paper


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## HelenMelb

Good luck-I hope it works wonders for you. I wish this trial was available to Australians!


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## Trevor

I think the reason for not having to sign an NDA is because I really have no info that isn't already public, haha. Being a blind trial and whatnot I don't really get to know much of anything.

Today was day 3, I've had two injections and will have a third on Friday and then after that it's every other day for the next 7 weeks, but at home from now on (thank god).

So far nothing to report as far as feeling any different but that's not exactly shocking since there's a 50/50 chance I'm not on anything, haha.

I guess all I can say is that it doesn't hurt, the injections are easy and the needle is super tiny.


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## tzvia

I'm in the process of getting approved to participate in the study!  Can't wait to hear how you do!


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## Trevor

Yay!

I am just about to head down to the clinic now for my last day of 'training' and to pick up all my stuff (meds, needles, sharps container, cooler bag for transport and alcohol swabs, plus journals and lab requisitions).

One week down - fifteen to go. I wasn't anticipating that this would be quite so torturous mentally, but I really just want it to be June!

I think I keep saying thanks but really thanks to everyone for the support  it makes a difference and hopefully this trial will make a difference too.


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## tzvia

How's it going, Trevor?


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## Trevor

Good!

Tomorrow is the first day of week 4, have to go do a set of labs this week but otherwise it's just steady as she goes for another 4 weeks.

I've got no way to be sure but I suspect I'm on the placebo so it's just a torturous waiting game for week 8 and the open-label portion of this rigmarole


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## Nipeli

Wow, this is so awesome, loving to read all this, my daughter really wants do this trial. Keep us posted.


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## F.u.Crohns

Plz keep us update whoever get accept to this trail. Good luck! ¡!!!!!


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## VeganOstomy

Trevor said:


> I've got no way to be sure but I suspect I'm on the placebo...


Does that mean you haven't been improving?


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## David

If you are on the placebo, let me be the first to say thank you.  I always feel bad for the people who end up being on the placebo but it's so important that some people are on it.  Even if a medication ends up not being efficacious, it's so important that these studies be done to add to the body of science.

I look forward to future updates


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## Trevor

There's a few reasons I'm pretty sure I'm not on the real deal, haha. I don't want to say too much for the sake of anyone else who may get into the trial. They may not notice everything I did and I don't wanna mess them up 

Almost halfway there!


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## Orchid

On the bright side you'll still get the real thing eventually!


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## Trevor

Exactly!

I get to be helpful and selfish all at once, haha.


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## Emily

Hi! It's been a while since I've been on the forum. But oh my gosh, this is very exciting to me! Trevor, just want to say way to go and even if you aren't getting the real deal, you are making an admirable contribution to medicine, science, and your fellow Crohnies worldwide. Can't wait to keep hearing about this!


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## Zeppy321

tzvia said:


> I'm in the process of getting approved to participate in the study!  Can't wait to hear how you do!


Hi tzvia I am also in the process of getting approved to participate in this study. I see you live in Pennsylvania - I live in Connecticut. My only concern is the cost of traveling back and forth to Canada 3 times. Have you looked into about how much travel will cost you ? I have never been to Canada. Do you think the $3800 in travel cost will be enough. I would really like to be a part of this study but am a little scared of how much the travel and stay will cost me.


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## tzvia

I do think it would be enough.  They also have discounted hotel rates for us.   I haven't checked prices, but I figure the flights should be maybe $700 x 3= $2100, and the hotel is $50 a night.  Should work out.  Check online an see how much flight are from your area.  I know the people who set the amount of reimbursement for us set it based on research they did on how much they think it would cost us.


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## Zeppy321

tzvia said:


> I do think it would be enough.  They also have discounted hotel rates for us.   I haven't checked prices, but I figure the flights should be maybe $700 x 3= $2100, and the hotel is $50 a night.  Should work out.  Check online an see how much flight are from your area.  I know the people who set the amount of reimbursement for us set it based on research they did on how much they think it would cost us.


Great thank you ! I will check online flight prices - this is very exciting ! :banana:


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## Trevor

Week 4 down, 4 more to go.

Woke up with quite a bad ear ache and a very swollen lymph node on my jaw/chin. Not really anything to do with the vaccine but it's annoying  green tea with honey and lemon by the gallon.

Otherwise status quo. Steady as she goes...


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## Adrie

Hi guys,

  My name is Adrienne. I was diagnosed with UC 10 years ago. 2 years ago flew down to Bahamas to receive this treatment (as the trial was not yet available in Canada) and was on the treatment for approx. 1 year. I was in full remission after 2 months of starting the injections, and have remained so since stopping (1 year).

I had no side effects, other than the redness at the injection site. 

In addition to being in remission, it has also helped my immune system in general. I used to get every common cold, and after the treatment, I found I rarely get sick.

Let me know if you have any questions about it. I was done with suffering, so I gave this treatment a chance, and I am so glad I did.


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## David

Thanks for sharing your story Adrie!  What medications did you try for your UC prior to trying the SSI?

And do you mind if I copy your post to this thread?


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## tzvia

That's amazing, Adrienne!  Did the trial provide the drug to for a whole year? I'm hoping to get into the trail. I'll know by next week if I'm in!


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## Adrie

I don't mind at all David. Share away. I was on Asacol and corticosteroids (Proctofoam), and Remicade prior to going on the SSi treatment. 

Tzvia - yes QuBiologics provided the vials for the entire year. It wasn't an official "trial" at that point, but rather an informal one.


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## tzvia

Just sent my labs in today to Qu!  I'll know in about two weeks if I'm going to Vancouver for the trial!
Zoe


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## Adrie

I hope it works out for you Tzvia!


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## Trevor

1/4 done !

May 5th (I think) is my half-way point when I go back to the clinic and they start me on round 2.

:-D

Zero info to report.


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## Trevor

Also: Adrie

Thank you so much for taking the time to post this. I have to drive to the clinic at least 5 more times (we all know how much fun driving can be when you're not feeling well) and hearing positiver testimonials is great motivation.

Not that I don't love you all and want to do this for everyone's benefit but when you're lying in bed at 7 am thinking about driving in rush-hour traffic for an hour it's easy to get discouraged 

Cheers!


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## Nipeli

Adrie, my daughter was diagnosed with UC in January 2013, and just reconfirmed diagnoses last week.  My question is, do you know if this treatment is still available for UC? We are willing to pay if it is.  thank you so much,


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## Adrie

Nipeli - I would contact Qu Biologics Directly and enquire about the Ssi treatment for UC in other parts of the world. I hope for your daughter's sake it is!

Trevor - good luck with the treatment journey - stick in there.


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## Trevor

Last set of blood tests Monday! Then meeting with the doc Thursday and then starting Phase II (open-label drug, presumably) on the following Monday the 5th of May :-D

I've been stuck at home so my buddy decided we should do a Podcast. Somewhat about Crohn's and the SSI a bit and Paleo and fitness if anyone wants to listen to us ramble.

http://traffic.libsyn.com/absolutelyseriously/1.mp3

- or -

www.TheAtlAtl.com


It's just two bored, twenty-something guys rambling, or a bit like Bob and Doug Mackenzie discuss sugar and Oreo cookies, haha. 

Warning: explicit.


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## Adrie

Thanks for keeping us posted Trevor. I really hope the word spreads about this trial and more people are able to get relief!!!


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## David

I echo Adrie.  Thank you so much on many different levels


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## Natalia Maria

Hi Trevor (and everyone else who has offered their input)

My name is Natalia Korczynski - I was one of the first people to participate in the trial with QU Biologics so I'm going to share my experience on here with you (a very positive one), and provide you with some more information. But, get ready for a novel!

The treatment, as I'm sure you already know, is called SSI Therapy: Site Specific Immunotherapy.

SSI is a vaccine that you administer yourself, every other day; the method is similar to insulin injections commonly used for diabetes for example. Prior to going on the vaccine you are trained by a health professional on how to administer the vaccine properly. The vaccine is composed of dead bacteria - it's all natural and there are no side effects as a result (at least I never experienced any while I was on the vaccine, nor did the patients that I spoke with who were also on it). The vaccine activates the body's immune system by targeting the organs affected by the disease, thereby reversing the chronic inflammation associated with Crohns, Colitis, and other autoimmune diseases. I was on the vaccine for just a little under a year (July 2011 to June 2012). It literally changed my life. I was originally diagnosed with Crohn's in November 2009 and for the first year after the diagnosis I was in excruciating pain, probably because I refused to take all of the crazy drugs that were being pushed my way by my GI specialists. But I was always a firm believer in taking the natural route so I saw a natural path and focused on trying to get better through a better diet, herbs, probiotics, digestive enzymes, the list goes on. And although that did help a little, the pain remained. I ended up in the hospital with a bowel obstruction June 2011 and it was shortly after that, that my natural path told me about the clinical trial for SSI therapy, originally started by Dr. Gunn, a doctor from BC. Since SSI therapy was still in its beginning stages at this point, I actually flew all the way to the Bahamas to participate in the trial since it had not been approved in Canada yet. But now it is, because they have seen so much success with it! I am no longer on the vaccine, and have been symptom free (knock on wood) for almost two years. Following a colonoscopy from March of last year, I was told that I am 100% in remission. I am going to attach a few links for you to check this out. It's for Qu Biologics - the company associated with the treatment, along with detailed information about the doctor and how this whole process got started. I can't stress enough how different my life is now. And that, coming from someone who wasn't even able to get out of bed for days to go to work, is saying a lot. I noticed a difference in my symptoms within 48 hours of taking the vaccine. If you can, I would strongly, strongly, recommend this treatment to anyone. Let me know if you have any other questions!


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## colleen.miller1428

To anyone who has signed up for the trial, I'd like to congratulate you for your bravery and willingness to try an up and coming treatment! As a compassionate care recipient, I know how doctors can react when you want to change things and take a risk. But this one is well worth it. So congratulations! Keep spreading the word and posting of your successes! 

Also, best of luck to any new comers to the trial! I hope you pass the enrolment process and see positive results!


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## Trevor

Thursday can't come soon enough.


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## Wendsjoy

Hey Trevor, any updates? I am headed there to be in the trial next week. This is a last resort for me. If it doesn't work I'll be forced to go on nasty biologics


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## Trevor

Literally sitting in the doctors office right now. Not sure if I get my first shot today or Monday or what but I'll try and post daily for the next week or two.

Hoping that I start today and by Monday I'd be on dose 3. But we shall see.


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## Wendsjoy

So were you getting the placebo then?


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## Trevor

!!!

Deemed a 'non-responder' and I get my first treatment of the open label vaccine on Monday morning !!!

!!!


(yes it would very much appear I was on the placebo)

(I've never been so excited to be a 'non-responder')


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## Trevor

And I got my new running shoes delivered today!

Everything is finally coming up Millhouse.


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## David

Hahah.  I'm excited for you Trevor!  God I hope this treatment does you well.  Either way, thank you so much for your courage and commitment to seeing it through.


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## Trevor

I'm excited and cautiously optimistic 

I'm just glad I get a chance to try it. Not knowing if it would have worked would have killed me.


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## Wendsjoy

Wow! That's good. I'm glad you are getting the med now. Please keep us updated. Prayers being sent your way! I'll be in your shoes next week!! So anxious! I hope I actually get the drug in the first week. We will see.


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## Trevor

If I'm feeling decent ill have to come visit! 

Actually. Next week like next Monday!? I'll be there every week. We'll probably meet!


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## Trevor

Too excited to make sense.

**every day next week


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## Wendsjoy

My first appt is the 9th. I fly in on the 8th. Are you there then?


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## Trevor

That's my last day! It's the reading day after the second injection and the day they give me all the kit to take home.


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## Wendsjoy

Awesome  maybe we will bump in to each other!


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## Trevor

That would be hilarious! Also: totally wrong of me, Friday is the third injection day. 

Either way I'll be sure to post updates. I'll either be a week ahead of you or nine weeks ahead of you. 

Super duper excited!!! :ylol2::ylol2::ylol2:

Can't wait!!! :sheep::sheep::sheep:


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## Tyler Wilson

Hey Everyone,
I also took the SSI treatment. I have been Crohn's free now for 3 years. I battled Crohn's for 5 years before starting the SSI treatment. I would strongly encourage anyone struggling with this disease to look into trial. Pass the word.

Trevor,
Hope it work as well for you as it did for me. Any questions don't hesitate to ask.


Tyler


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## VeganOstomy

Tyler Wilson said:


> Hey Everyone,
> I also took the SSI treatment. I have been Crohn's free now for 3 years. I battled Crohn's for 5 years before starting the SSI treatment. I would strongly encourage anyone struggling with this disease to look into trial. Pass the word.
> 
> Trevor,
> Hope it work as well for you as it did for me. Any questions don't hesitate to ask.
> 
> 
> Tyler


I watched your video when I heard about the therapy.  I'm so glad it worked for you!  I


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## Trevor

Thanks, Tyler!

No questions at the moment, just a whole lot of finger crossing.


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## Trevor

Tee minus three hours!

Just for comparisons sake and so I don't forget (because I will) I'm currently at around 3-6 BM's, mild to moderate stomach pain, lower right abdomen, 10 mg Pred and 3 x Mezavant tablets daily. Oh and fatigue, lots of fatigue.

That's down from 15-20 BM's, severe stomach pain and 60 mg Pred in November/December, 2013. 

I usually start feeling worse and stop improving on Pred right around the 10 mg mark.


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## David

Good luck Trevor 

Are you currently tapering the prednisone or on a static amount for awhile?


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## Trevor

Thanks!

Currently tapering - last week was 15 mg / 10 mg on alternating days and then this week at 10 mg and then next week 10 mg / 7.5 on alternating days.

Should be pretty much off it right abut the same time I finish the vaccine off.


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## David

Get your shot Trevor?


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## Trevor

Sure did! Went very smoothly. Didn't feel anything at all, all afternoon, really.


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## Wendsjoy

Trevor! That is sooooo exciting! Praying that relief from symptoms starts sooner than later! Keep the updates coming!


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## Trevor

I'd be curious about everyone else's treatment protocols? It seems like they've pretty well settled on 8 weeks as the maximum necessary time needed but I'd be very curious to know if they've altered the procedure much aside from shortening the treatment length? Average dose? Timing? Is the rash always how they've controlled the dose?

There's a question for you Tyler Wilson or Adrie or anyone else who's already been through the treatment.


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## Wendsjoy

Trevor,  I was under the impression that they allowed for 16 weeks of the drug...or 24... They said that 4 months of treatment is the standard for Crohn's. 
I fly out tomorrow!


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## Trevor

I could be totally wrong. I just assumed 8 weeks was the length because of the first phase but my reading comprehension skills are suspect.


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## Trevor

Confirmed with the trial nurse today that a full course is 8 weeks and after week 16 of the trial there's no treatment, just phone calls.

That's part of the beauty of this :-D no pills to take, no injections forever :-D


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## Trevor

So we're almost 72 hours from the first injection and about 20 from the second. I just slept for 9-ish hours which is fantastic for me. Usually it's a struggle to get 6 or 7.

Last night my stomach was quite upset about something. Lots of gas and bloating. Usually I'd associate that with bad food but I hadn't eaten anything I haven't been eating successfully for the last few months.

We'll see how today and tomorrow goes, I guess :-D so far so good.


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## pmitra0123

Good luck Trevor! Pulling for you! Hope you see dramatic results soon!!


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## Trevor

Still mostly just feeling 'funny'. Not a lot to report otherwise. But hey :-D funny is a darn good start.


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## Trevor

Hmm. Very cramped and/or bloated. Uncertainty because this is very much new, gas and bloating but no BM's.

Uncomfortable but I'm sticking with the anything new is good theory until proven otherwise :-D


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## David

Trevor, so you've gone from 3-6 loose bm's to no bm's and cramped and bloated?


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## Tyler Wilson

You should see improvements within the 1st week. I was very sick when I started the SSI and within 7 days I improved drastically. It's a good sign that your stools have improved. You want to try and maintain a loonie / toonie size reaction site. This is exciting. I hope it goes well for you.


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## Trevor

Well not no BM's. Just none last night when I was feeling not great. Usually when I don't feel well like that there's lots of trips to the bathroom.

I am improving though. I'm hesitant to quantify it because this week was strange as far as all the driving and not eating normally. But I stayed home and ate normally yesterday and took no immodium (usually 4 tabs daily) and so far today just 1 solid BM. Granted I've only been awake for 30 minutes but that's a pretty darn good start.


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## Trevor

Thing are much less messy, if that makes sense? Even when I had formed BM's previously they were not 'dry' like they are now. 

Sorry if that's slightly graphic but it just struck me what a significant change that likely is


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## David

Nothing is too graphic Trevor.  People are dying for details on all this.  As far as I'm concerned, feel free to count the kernals of corn and peanuts.


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## Wendsjoy

Trevor, thank you so much for all the details and remembering to update! I don't mind the graphics. We are all there with you.  
I had my physical on Friday and met with dr Bressler. I was declared sick enough to participate.  I receive my first dose on Monday as part of the randomized study. 
I am praying for you and myself!! Keep the updates coming and I will as well. Have been pretty sick since I got here so it will be easy for me to determine if it is helping.


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## Trevor

Awesome!

In some ways I wish I was as sick as I was in December and January so it would be a more dramatic improvement. But wishing to be sicker so you can get more better is not very logical 

Oh and David, I would count them but no corn or peanuts on Paleo AI :lol: I'll for sure keep up with the details though!


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## pmitra0123

Thanks guys for sharing your info - keep all the details coming...they are great! Trevor - so you are currently still at around 6 loose bowel movements a day?


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## Trevor

I'd say 6 + - 3. So anywhere from 3 to 9 and lately more towards the formed than loose end of things but as previously mentioned still plenty of room for improvement.

Today was 3 this morning, all within 2 hours of getting up and I think that's likely it for the day.

I have absolute faith we'll get to the magic single BM a day. Things appear to be heading that way. I think the big thing for me will be can I get there and stay there without steriods.


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## rollinstone

You'll get there bro, from what I understand, each injection you get your body produces macrophages, which is what they theorize is faulty, in a weird analogy, i see it kinda like restarting a computer system when it freezes.. After 8 weeks of it your immune system should be running smoothly. I got my fingers crossed for you. And thanks heaps for keeping us updated and for going through the placebo so patiently. I believe this thing is gonna cure you, much like I believe it cured Tyler. God bless


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## Trevor

Another day, another 3 solid BM's  all within 5 hours of waking up.

Maybe more significant is the cramping/pain still. Nothing drastic just not normal. In my mind that's my immune system waking up and doing something it wasn't doing before  lets hope.


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## David

Prior to beginning the trial, how long had it been since you had experienced a solid BM?


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## pmitra0123

So Trevor has it been 3 bowel movements and done, no more the rest of the day? If so, that sounds like progress since before it was anything from 3-9 which  I'm guessing means an average of 6?


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## VeganOstomy

Trevor said:


> Another day, another 3 solid BM's  all within 5 hours of waking up.


Are you keeping a food diary too so you can see if the BM's are related to a change in what you're eating, when you're eating or how much you're eating?


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## Trevor

I don't keep a written food diary but I do pay close attention to what/when I eat and if and how it effects things. I'm eating what is essentially Paleo with some tweaks (Kefier and scd yogurt, mostly).

I would say pre-Crohn's, David, for the type of BM some have been. Maybe a few years ago when I was first on Pred but it would have only been briefly and only when on Pred. So that's certainly progress.


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## VeganOstomy

Trevor said:


> I'm eating what is essentially Paleo with some tweaks (Kefier and scd yogurt, mostly).


Did you just start this diet recently?  A well-known side-effect to eating paleo is constipation, which sounds like this crampy/bloated feeling you're talking about with no BM's after the morning (you _should_ be having a BM after each meal), but I'm crossing my fingers that it's the meds kicking in! :mario2:


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## Trevor

Haha, Paleo is actually quite liberal for me. I'm use to GAPS / SCD / Paleo AI.

I think that I fast all day and only eat in the evenings for the most part probably explains the timing of things.


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## VeganOstomy

Trevor said:


> I think that I fast all day and only eat in the evenings for the most part probably explains the timing of things.


Damn, that's what I thought.  Even with my ileostomy, I can slow down my output to nothing all afternoon if I skip eating at a certain time. 

Are you fasting for any particular reason during the day?


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## Trevor

Just for ease of mobility and work. On the weekends I do eat earlier and I am hoping to start eating breakfast and lunch next week too. 

Also going from 1 g a day of MM to .5 g a day this week.

Oh and I've been coming off 8 mg of Immodium daily too. Today only 4 mg, hopefully that continues.


Lots of moving parts :-/


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## Trevor

Just two today and they were both within an hour of waking up. That's certainly progress. Second could have been more solid but I cracked and had a Gf beef last night so maybe not shocking 

More relevant, IMHO, would be the new pain and cramping. Something new is hurting (comes and goes, belly button region, sharp and sudden, 2 or 3 out of 10) and while it's super subjective and I have no idea what it might be I feel like it's got to be a good sign. Doesn't feel like any other Crohn's pains I've had.

Should almost be at my max dose. Sometime this week. Thursday or Saturday.


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## Wendsjoy

Thanks again for updating Trevor  I had my first dose yesterday. Not feeling well at all today. Kinda dizzy and lots of bloating and gas. My belly is making all kinds of noise. I have had extra BM's today, although not watery, pretty formed but painful.  I'm pretty sure I got the med and not the placebo; these changes are very drastic way outside of my norm. I get my second dose tm, based on what they said today I will be increasing my dose by 0.01. I am holding out hope that the worsening symptoms are temporary and that I will feel better than ever soon!


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## David

Trevor said:


> Just two today and they were both within an hour of waking up. That's certainly progress. Second could have been more solid but I cracked and had a Gf beef last night so maybe not shocking
> 
> More relevant, IMHO, would be the new pain and cramping. Something new is hurting (comes and goes, belly button region, sharp and sudden, 2 or 3 out of 10) and while it's super subjective and I have no idea what it might be I feel like it's got to be a good sign. Doesn't feel like any other Crohn's pains I've had.
> 
> Should almost be at my max dose. Sometime this week. Thursday or Saturday.


I just wonder if it is the solid fecal matter moving across inflamed intestine (that is hopefully healing  )  Total guess of course.


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## David

Wendsjoy said:


> Thanks again for updating Trevor  I had my first dose yesterday. Not feeling well at all today. Kinda dizzy and lots of bloating and gas. My belly is making all kinds of noise. I have had extra BM's today, although not watery, pretty formed but painful.  I'm pretty sure I got the med and not the placebo; these changes are very drastic way outside of my norm. I get my second dose tm, based on what they said today I will be increasing my dose by 0.01. I am holding out hope that the worsening symptoms are temporary and that I will feel better than ever soon!


Congratulations on your first dose!

We're all pulling for you.  Please keep us updated!


----------



## Trevor

Wendsjoy the first day or two were the worst, for sure! Hang in there 

And I think that's (hopefully) a good bet, David. My GI said my colon looked pretty healthy on my last scope (February-ish) and was healing nicely so whatever was still inflamed was higher up, even back then.


----------



## bees

That is similar to my experience, it seems like this treatment causes our digestion to improve first which causes some uncomfortable weeks of healing.

Some diet modifications would be ideal with this treatment during the beginning.

I took some dulcolax during the first few days that I started feeling constipated since I was worried about getting an obstruction.

With Remicade/prednisone it felt like the drugs healed my intestines, which got rid of the cramping and spasms, causing more solid BMs.

I'm on week 5 of treatment now, there's no more sharp pain when I poke around the terminal ileum, just a bit of discomfort from digestion as I've been eating a lot more variety again and making some mistakes. So happy to be back to my active lifestyle, biked 20km today


----------



## Trevor

Uncomfortable would be exactly how I would describe it. For anyone who's had moderate to severe Crohn's this is a walk in the park, pain-wise.

But I'm glad that's what I should be experiencing 

And take it for what it's worth, but my right ankle and left wrist have both been throbbing. Both of those joints have extensive scar tissue from repeated serious sprains and in the past have always given me trouble when my Crohn's is acting up. My ankle sometimes gets really hot and swells up to the size of a softball. So given what the vaccine is suppose to do and what my past experience has been with those joints and inflammation I'm intrigued.


----------



## rollinstone

Oh man I'm so excited for what this vaccine is going to be able to do for people!


----------



## HelenMelb

Trevor and Wendsjoy, thank you so much for keeping us informed about how you are going on this trial. I think the SSI vaccine is one of the most promising genuine hopes for the treatment/cure of crohn's. You are really helping so many people by participating-thank you again!


----------



## Trevor

Nothing exciting to report today. Other than we posted a new Podcast.

It's been a couple weeks so I somewhat forget what was discussed but I know we talk about Crohn's/IBD and the SSI and LDN and MM I think.

http://fraserriverforager.com/2014/05/14/episode-3-moareos/


**NSFW or PG-18 or something


----------



## Poppysocks

Appreciate the updates Trevor. I might be doing this trial, it will be a ways off from now though.


----------



## Trevor

No change in frequency but better form and less urgency. Ankle is a little swollen and wrist is killing me :-/

Today was a shot day. Next one is Saturday!


----------



## David

Is the ankle and wrist stuff new?


----------



## Wendsjoy

Injection #3 tomorrow. I am doing better. The side effects have died down and I am feeling more like myself now. I slept 12 hours last night and only had one BM today; usually when I have a bad day or two like yesterday and Tuesday (had 8-12 BMs) I'll have a good day, like today, so I don't know yet if it's medicine related or just cause I cleared myself out. Time will tell. ...this mornings BM was loose and gross but the urgency wasn't quite as bad and only one trip to the bathroom is great! Typically I go 3-4 times in the morning. I also feel pretty funny. I don't know how to describe it accurately...I don't feel bad, I just feel different. I don't have my usual right and left sided pain and I don't have reflux as much. I do have some joint pain that I typically will have during a flair but nothing too bad. So...anyway sorry for the gross details but I want to give as much detail as I have to help as many people as I can  I'll keep updating as things progress. Still praying that this is the answer so many of us have been searching for.


----------



## Trevor

Hahaha. Too funny. That's so similar to what has been happening for me, Wendsjoy.

David, the joint stuff is new this time but an old symptom that I primarily associate with a flare. I have extensive scar tissue from sprains in my right ankle, which is currently swollen, and my left wrist, which is throbbing like heck. My other ankle and wrist also have damage from sprains but much more minor and I don't really notice them at all, at the moment.

I'd have to read back in the thread (mm is not good for memory) but it was either yesterday or the day before that I noticed they were stiff and painful.


----------



## Trevor

So. Just once today. First thing this morning.

Not getting too excited. It's just one day. But that's reasonably awesome.

Breakfast: 4 egg yolks, 4 sausages, sauerkraut, sprouts and black tea with milk and honey
Lunch: sweet potato crackers and aged cheddar, apple cider
Dinner: pork chop, salad, red wine, green beans, sweet potato

Today was an injection day. Next one is Monday!

Wrist and ankle are feeling better.


----------



## David

:dance:


----------



## pmitra0123

Great news Trevor! So, just one bowel movement for the day? Have you ever had just one bowel movement in a day since being diagnosed? I know I haven't!


----------



## Crohn2357

Trevor, thank you very much for sharing. I wonder if every phase of the study progresses with very positive results; when will the drug approval happen?


----------



## Wendsjoy

Hey everyone, been a few days, thought I'd give an update. So today was injection day 4 for me. Yesterday was a rough day but I was traveling and ate a piece of pizza for dinner (never a good idea, but I was passing through Chicago and starving) so I'm thinking that it was not a good day from the stress and bad food. Today is better. My BM's have, like Trevor, been slowing gradually. I had 2 days in a row of only 1 BM in the morning and that's it! I do still have some pain in my right side but not as bad as before and some joint pain. The amount of blood that I typically see seems to be lessening as well. Hopefully these things will continue to improve. I will keep updating as things move along


----------



## David

That's awesome about the 1 BM Wendsjoy!  Congratulations 

Sorry you've had some rough days but I pray that each day is an improvement from here on out.


----------



## pmitra0123

Great news Wendsjoy! What were your symptoms (number of bowel movements, frequency, urgency, etc.) like before the trial?


----------



## Wendsjoy

Pmitra, my Crohn's is throughout my small bowel mostly concentrated in the ileum. My worst symptom is pain. I have it in my sides, lower back, stomach, esophagus, tailbone, rectum and even my jaw. I also have joint pain when I am 'flaring' but that seems to be all the time  now a days. My BM's range from 3-12 a day. Urgency is very bad in the mornings. I tend to wake up in the worst pain of the day and most of my BM's occur before early afternoon.  They are bloody and mucousy almost always and very painful. I could write a book but  I have tried everything to relieve the constant inflammation and  pain including SCD diet and HBOT  with acupuncture. The only thing that provides any relief is acupuncture. I have not tried any meds except LDN and entocort.  Neither of which did much. I have such high hopes for this study. I will be devastated if it doesn't work. 
I had a pretty rough day again today. I don't know why I've been up and down so much. I had some more pain and extra BM's. No blood, but very nasty. Not really formed at all. I was so excited to have some initial relief and improvements but after today  I  am scared that the med won't work at all. But maybe it's too early for such big improvements. My body is going to take a while to heal I guess. I read all the posts of those who were in the study and are better now...wondering how long it took to see drastic improvements or if they were more slow and gradual? It has only been a week and tomorrow is another injection day. I am praying so hard that I will improve! 
Trevor, are you experiencing any ups and downs like this?  How are you feeling lately?


----------



## MamaHenn

I'm subscribing to this thread. Thank you all for sharing your experiences with us.


----------



## pmitra0123

Hang in there Wendsoy! No blood is a good sign! I am sure there are ups and downs in the healing process.  What were the total # of bowel movements today?


----------



## Wendsjoy

Today it was 5 painful BM's before I took Imodium which stopped them but the pain remained, of course.


----------



## rollinstone

Hang in there wendsjoy you're only a week into the trial, early days still, there are many variables to consider also, I.e is your diet fairly stable
Or have you been eating different things, also keep in mind that you could have got the placebo, but anyhow, stay strong! You're gonna get through this and have faith, I really think the SSI vaccine is gonna be the golden ticket. Hope you start feeling better real soon!


----------



## Trevor

Up to, or very near my full-dose.

I went up to my the family ranch this weekend (4 hour drive) for the first time in 6 months so that's a good sign. Felt great the first day but was exhuasted by day two. Seem to be bouncing between 1 - 4 a day depending on conditions last week. Usually much less urgency.

Joints have cooled off. Less pain in general. Down to 5 mg Pred this week. Just for context I'd usually be back to loose stools and 5-10 bathroom trips (or worse) once I get below 10 or 15 mg of Pred.

6-ish more weeks


----------



## Trevor

Other fun facts:

The scar tissue in my lip (sucker punched at a party when I was 19) and a funny little bump I've had on my side forever are both red and painful/swollen.

And my guts are more sore now than the sharp pain from last week. Feels like healing? Whatever that means.

Super subjective but that's as good as my science skills get


----------



## Trevor

Super nauseous today. Was a little yesterday but today is much worse.

Threw up  that always helps. Not sure if it's related or what, but the only time I've been nauseous with crohns really was when I was a) deathly ill or b) was recovering from being deathly ill.

Since everything else seems to be going decently I'm filing this under the recovering heading.

The trial nurse made sure I noted it in the journal but seemed to think it was normal and said not to worry unless I developed more severe symptoms or a fever over 100.

Hard to say how I'm feeling otherwise as the urge to chuck is pretty distracting.

Forward, march


----------



## Poppysocks

updates?


----------



## Trevor

Seem to be over the chuking thing.

Nothing else new or different...


Edit: partly wrong, new podcast with some SSI stuff from a couple weeks back, I think it's more episode 5 and 6 when I actually start taking the SSI and then probably 7-8 + will be from now on. 

http://traffic.libsyn.com/absolutelyseriously/The_Atl_Atl_Daily_-_Episode_4.mp3


----------



## Wendsjoy

Same here too...not much improvement yet. Still up and down and dealing with the same stuff. Holding out for some much anticipated improvement soon!! Today started week 3 and injection #8.


----------



## Trevor

Not that I don't normally sound nuts but I'm really swinging for the fences this time. Some random observations...

I'm 'pinker', my skin tone has visually changed in the last week or two. Super subjective but I am a trained photographer for what that's worth. Colour and skin tone is kinda our thing...

My guts hurt different. I honestly don't know how else to say. I've never had a ton of persistent pain, really, but how things feel now reminds me very much if how I felt when I was first on Pred. Just the way my guts feel. Nothing else is similar.

My skin has been improving for months now. Ever since I really cleaned up my diet 100% and started taking magnesium but it's really REALLY improved the last few days.

Despite much better skin quality and texture and almost being off Pred and eating well I seem to be getting pimples on my face. I do tend to get that with Pred at doses above 30 or 40 mg but I've been at or below 10 mg for pretty well a month now and below 20 for several.

Could be totally unrelated. But wanted to mention it all for posterities sake.

Or posteriors sake. Something like that.


----------



## rollinstone

Hang in there guys, just wanted to chime in on the pred thing, acne generally always pops up for a bit when you taper off it. Anyway, just wishing you guys well!


----------



## Wendsjoy

I can agree with Trevor. I feel the same way. It's hard to explain but I feel different. My symptoms have changed. My guts hurt in different places than before and sometime I have worse diarrhea. It's so strange. I don't know how else to describe it. 
On the skin note...mine has been awful. Kinda like when I'm in a bad flare. I have pimples on my face and bumps on my arms, which generally pop out when I am really bad. I have also noticed that I have some anxiety feelings happening. But even that is strange. Usually when I am in a flare I will have terrible sleep quality and awful anxiety. Right now I have mild anxiety but I'm sleeping better than before. Again, it's so strange. 
Anyway...I hope these weird updates actually help people in some way. I just feel like I'm rambling.


----------



## Mondowicked

I appreciate these stories! So much so that I've started the process of getting approved for the trial. Friday, I'm getting all of my paperwork together, so I should be talking to the study nurse early next week to start the informed consent and official screening labs. Fingers crossed they let me in.


----------



## Trevor

Mondo! Yay! My gf's college roommate is waiting to hear back from Qu right now. Hopefully he gets in too!

The faster we fill this one up the faster they get to the next stage! And hopefully onto prescription pads shortly thereafter if it proves as effective as we hope :-D


----------



## pmitra0123

Trevor how many bowel movements a day now?  You are 3 weeks in, yeah?


----------



## Trevor

Usually just twice in the morning. But it still varies.

Completed three weeks! Yup.


----------



## pmitra0123

Any blood? Two a day in the morning is wonderful! Hope you continue to improve until you are in a permanent remission!!


----------



## Trevor

Nope! Or mucus or anything else. I've got to say, it's maybe not the miraculous instant recovery I'd like but so far, especially if things keep trending upwards, so good.

I'm still only really eating in the afternoon/evening but I'm getting plenty of calories.


----------



## trichard10

Thanks for keeping us updated Trevor. Following


----------



## Wendsjoy

Agreed Trevor! I have a friend applying for the study too…hopefully they'll close it soon with the 60 participants and be able to get it out to the public as an approved drug for IBD. 

I wanted to chime in with an update…i still feel pretty crappy. I am in week 3 with injection #9 today. Keeping the faith that it will work eventually. I have a lot of nausea this week, my appetite is totally lacking. I don't eat much in the morning either (that's my worst time) but the last few days I haven't really wanted to eat anything at all. I also have pain and bleeding now as my fissure has opened back up and the extra bowel movements make that agony.  this feels like a bad flare with everything that i am feeling, my dr wants to start pred, but I am holding out as long as i can for the ssi to work! 

on a positive note, I had a cold coming on early this week. I woke up with a horribly sore throat and cough and runny nose on sunday. Typically I will be sick with something like that for a while so I was bracing my self for worse crohn's symptoms and a bad cold…but i am completely better ALREADY! I can only attribute it to the SSI because that is the only thing that is new. Maybe it's starting to work and all the other symptoms will follow along?? one can only pray!


----------



## Trevor

Freudian slip? I accidentally threw away my Imodium when I was cleaning up my bathroom the other day. Went from 2x 2 mg tabs a day to zero and if anything I think I feel better.

So where I'm at:

3 x Mezavant
5 mg Pred

Various nutrient/herbal supplements
Various pre & pro biotics 
1/2 to 1 g MM high-CBD 

Chris Kresser Paleo/Paleo AI (custom-Paleo-based-elimination-diet is too wordy)

and of course the SSI.


----------



## Trevor

This week has been steady, twice a day in the morning and then today just once so far 

More importantly, last night I could feel things moving sllllowly through the system (no gurgling, the very first thing I noticed before I was diagnosed) and it HURT, like owe. I don't know if it was in this thread or the other but one of the compassionate care folks who was right around week 3/4 described exactly the same thing.

:-D


----------



## bees

I'm halfway through week 7. Pain at the terminal ileum (where most of my inflammation happened) is gone. A week or two ago I started getting really solid BMs, too solid, I was massively bloated in the evening and in a lot of discomfort, spent a few days taking dulcolax and limiting fiber in my diet and the bloating is gone. I was worried that I may have developed a blockage or stricturing (doc said my terminal ileum looks ugly during the last scope about a year ago), but it seems to be getting better now.

I agree with Wendsjoy that it feels like the pain has moved elsewhere, I think the new soreness for me was mainly from that week of bloating I had, my digestive system may not be used to such solid BMs and I'm sure there's some stricturing.

I've been reading about cases where people have 'beat' their strictures with careful diet and their strictures eventually loosened up, trying to avoid surgery as long as I can!


----------



## pmitra0123

Thanks Bees for sharing info with us!  So, how many bowel movements a day before the trial and how many now? Blood? Mucus? Urgency?


----------



## Trevor

Week 4 is in the books. 

Twice this morning. Same old - same old. Ha.

I did have some pretty severe cramping this weekend. Really sharp, sudden pain. Bloating. Soreness.

But still improving overall


----------



## Trevor

Another podcast. I'll quit notifying about new episodes unless there's a really significant one as I think the link is probably enough places in this thread. And in my sig.

http://fraserriverforager.com/2014/06/03/episode-6-measure-once-cut-twice/

If you just want the SSI news and not our rambling I think we cover it right off the top on this one.


----------



## trichard10

Travis do you still believe you received a placebo treatment?


----------



## Trevor

Nope! 4 weeks of the real stuff for sure 

The second phase is open-label. No chance of a Placebo.


----------



## bees

pmitra0123 said:


> Thanks Bees for sharing info with us!  So, how many bowel movements a day before the trial and how many now? Blood? Mucus? Urgency?


My BMs are more solid and less frequent, but that has never as big of an issue with my Crohns as the pain and fatigue I experienced from inflammation. It's been a great month thanks to this treatment, I hope the results persist!


----------



## Trevor

Today is great! Bit of a blip last week, few off days, not totally certain why but I did start a new vial of the vaccine, that's the only thing I can figure. 

I'm still kinda in cautious-optimism mode but fingers crossed.


----------



## pmitra0123

What kind of blip? Like what do you mean?


----------



## Jay Woodman

Tyler Wilson said:


> Hey Everyone,
> I also took the SSI treatment. I have been Crohn's free now for 3 years. I battled Crohn's for 5 years before starting the SSI treatment. I would strongly encourage anyone struggling with this disease to look into trial. Pass the word.
> 
> Trevor,
> Hope it work as well for you as it did for me. Any questions don't hesitate to ask.
> 
> 
> Tyler


  I have Perianal Crohns with abscesses,fistulas & now setons. I was wondering if any SSI participants have had perianal fistulas & if so has there been any success with closing the fistulas?


----------



## Tyler Wilson

Jay,
Yes there has been one patient that I know of that had fistulas as a result of her Crohn's disease. She is currently free from Crohn's and the fistulas have gone completely.


----------



## Tyler Wilson

Trevor,
How many mg of the SSI are you taking?


----------



## Trevor

I've maxed out around .14 and seem to be holding steady with that. 

Blip meaning I didn't feel as well. It's hard to quantify, unfortunately.

I actually ate breakfast and went to work IN THE SAME DAY today. That's a minor miracle right there.


----------



## Tyler Wilson

That's good. I was at .12 as a max.


----------



## Wendsjoy

Hey All! Sorry it's been so long since I have updated...
I have been doing better  finally! It hasn't been as up and down lately. I have been feeling pretty much the same everyday. I have had several days in a row of only one BM and feeling pretty good. My fissure is actually healing, already! Usually that takes forever! I am still cautiously optimistic, but this is the most improvement I have seen. Ever. I even ate a fast food burger, just to see if it's a fluke that i have been doing so well, and I was totally fine the next day! I would usually be very sick, but I wasn't. 
I am still feeling some pain and bloating and sometimes I do have worse diarrhea. My BM's are still not 'normal', but things are looking up! 
Now on to week 5!


----------



## David

Great news Wendsjoy!  Fingers remain crossed for you


----------



## Trevor

I cut my thumb the other day and was shocked at how fast and how clean it healed. Macrophages are pretty nifty little things, apparently.

Hopefully same goes for your fissure, Wendsjoy.


----------



## bees

I'm back in Vancouver for my 2nd visit, have been deemed a 'responder' to the drug and will be taking it for another 2 months.

Still feeling great!


----------



## rollinstone

Man I hope this thing becomes avail globally real soon!


----------



## Tyler Wilson

That's awesome bees


----------



## Bareket

Hi All- So excited for you, this sounds like a great drug.

It seems that Qu is pushing for a Compassionate Use indication from the FDA. If they get this, they can fast track the drug through FDA approval. 

http://www.reuters.com/article/2014/04/28/idUSnMKWgGjK4a+1d4+MKW20140428

I don't have any inside information, just what I gleaned from the internet. But as it can take years to get drugs approved by the FDA, getting the Compassionate use indication would be a great thing. All the work Trevor, Wednesjoy, Bees, Tzvia and other are doing to participate in this study will really help this cause. I hope this pans out to be great and that all of you can have access if you want it.


----------



## David

Barekat, where did you read that Qu is pushing for compassionate use for the FDA to get fast tracked?  I read the article you linked, but didn't see that there.

Thanks!


----------



## Bareket

Hi David, didn't read it. But given the name of their program and presentation poster it all fits. I work for a Pharma company and this is just the kind of thing that help fast track FDA approval. Here is information on Compassionate Use: 
http://www.fda.gov/ForConsumers/ByA...es/AccesstoInvestigationalDrugs/ucm176098.htm

Maybe it's just wishful thinking on my part. But I'm just really hopeful that this drug doesn't languish in the really tough and sometimes illogical FDA approval process.


----------



## David

Ah, I see.

We're a ways off from that, but hopefully all goes so well that we can indeed get SSI fast tracked   If the results from this trial and the phase III trial are good, god knows I'll be doing everything I can to help it get fast tracked


----------



## Reef08

Those of you on SSI, have you noticed any beneficial side effects on other problems like acne, food intolerances, seasonal allergies, etc?


----------



## Trevor

I haven't gotten any allergies/hay fever this year yet. Usually around this time I'd be a mess for a few weeks. Or since my late teens thats the case. I don't remember having allergies as a kid.

Acne no, but I've been on and now almost off Pred so may have been hard to tell.

And food intolerances, maybe. My food and digestion issues have improved greatly from January to now but they were improving when I wasn't on the SSI as well.


----------



## David

How are you feeling Trevor?  Anything to update in that regard?


----------



## Trevor

Today, pretty awful, haha. It seems like once a week-ish I have a much worse day or two.

Still improving overall though. More energy, more appetite, less urgency and thus less anxiety.

I dunno, I'm almost at the end now. Hopefully the nurse was right about the 'keep getting better even after you're done the injections' thing.


----------



## pmitra0123

Oh no Trevor! Why awful? What happened?  How many more weeks to go? I was hoping you would be in remission at this point - maybe you are.

TYLER, and some of the other experienced members - did you all get this type of once a week negative days like Trevor is getting in the early going? The macrophages should be recruited to the area and shutting down the inflammatory response, shouldn't they? Maybe this is some sort of non-related irritable bowel like symptom that Trevor is experiencing? Trevor - do you notice any foods/habits that make you feel this once a week negative day?


----------



## Trevor

Don't panic yet, pmitra0123  firstly, while I think all 10 CC patients reported improvements I believe 7 made it into remission and 5 sustained remission? Someone correct me if I am wrong but I don't think it was 100% sustained remission and it was a very small group. I am not saying I'm not one of those sustained remission people, but everything in perspective.

I've been shying away from being too specific about things because I a) don't want to get anyone too excited and b) how I feel is very hard to describe and if I just reported the physical symptoms day by day I think things would seem worse than they are or like I am not really improving, which I absolutely am.

One of the very first things when I first got sick that I noticed were skin tags, that's how I knew I likely had Crohn's and not UC. The last couple of weeks they seem to be greatly reduced and/or going away entirely. This, to me, is a much more promising sign than how I might feel on any one day. And even the 'bad' days are still 1000x better than any day in December.

The how I feel thing is trickier. I feel 'different' and I have no idea how to describe it other than when I was on Pred the first time, when I was getting better this is how my guts felt. I really don't know how to describe it, unfortunately, other than it's just not the same as before, haha. 

So I'm pretty optimistic  As long as something is going on I am happy and something is for sure still going on. I've kinda decided to give it until September and then decide where I am, and if I seem to be staying there without steroids.

That's maybe the biggest thing to stress. If the SSI has gotten me to a place where I don't have to take anything stronger than Mezavant and MM and I continue to slowly get better, or even just not get worse, that's a huge win in my books and a much, much better place than where I was.


----------



## Poppysocks

Trevor, what is your diet like? I know you mentioned you were doing some sort of paleo. But what exactly are you eating?


----------



## pmitra0123

Well I guess the main thing Trevor - still no blood and no mucus? That would be a good sign in terms of inflammation.


----------



## Trevor

What I'd call Chris Kresser Paleo for the most part.

Orthodox Paleo with various, high-fat, grass-fed dairy products and I will eat some rice or oats from time to time.

Mainly grass-fed meats and organic fruits and vegetables  lots of fermented foods.

No blood no mucus and the last few days have been pretty stellar! This is the most 'normal' I've felt in two years.


----------



## Poppysocks

Updates?


----------



## Wendsjoy

I am the same. Still doing better but not where I want to be. I am in week 7 now. BM's are still at 1-2 day with little mucous and no blood. I am still up and down although not as much, some days I feel great and almost like I'm not even sick. Other days I feel awful (bloated, tired, anxious, pain and pressure...etc), it's like the disease has a hold on my body and is fighting to keep it in it's grips. I sometimes imagine a horrible invisible demon with its claws in my intestines and my body is trying to fight it off. Some days it wins others it doesn't. It's so strange. 
Overall though, I do feel better. My energy level is better. My sleep is better. The BM's that I have are more formed and less painful. I am still very hopeful that at the end of this I will be in remission. 
I head back to vancouver in a week and a half. I'm hoping they will share my lab results with me and they will show improvement. I can 'feel' better everyday, but until my lab results show improvement I won't believe the med works. I feel like I need those improvements in my lab work to prove I am really healing. 
Sorry if this post is weird or rambly. I am not sure how else to describe things. Haha


----------



## rollinstone

You'll get there! How many weeks have you been on it now? And did you have blood etc before? Remember it takes a while to heal up. Hope you get to where you want to be!


----------



## pmitra0123

Hang in there Wensdjoy! You def have a right to your labs - just ask them and I am sure they will give you a photocopy of them.  One question for you - before you did this trial medicine, did you have ups and downs with good days like these where you didn't feel sick? Or is this something new that you started feeling after you entered the trial?


----------



## Wendsjoy

Joshuaaa said:


> You'll get there! How many weeks have you been on it now? And did you have blood etc before? Remember it takes a while to heal up. Hope you get to where you want to be!


I am on day 3 of week 7. I did have blood and mucous before so that is an improvement.


----------



## Wendsjoy

pmitra0123 said:


> Hang in there Wensdjoy! You def have a right to your labs - just ask them and I am sure they will give you a photocopy of them.  One question for you - before you did this trial medicine, did you have ups and downs with good days like these where you didn't feel sick? Or is this something new that you started feeling after you entered the trial?


I am sure they will! I will definitely ask for the labs. I did have ups and downs before the trial, however my 'ups' weren't as long or as good as now.


----------



## Jajabinks

Adrie said:


> Hi guys,
> 
> My name is Adrienne. I was diagnosed with UC 10 years ago. 2 years ago flew down to Bahamas to receive this treatment (as the trial was not yet available in Canada) and was on the treatment for approx. 1 year. I was in full remission after 2 months of starting the injections, and have remained so since stopping (1 year).
> 
> I had no side effects, other than the redness at the injection site.
> 
> In addition to being in remission, it has also helped my immune system in general. I used to get every common cold, and after the treatment, I found I rarely get sick.
> 
> Let me know if you have any questions about it. I was done with suffering, so I gave this treatment a chance, and I am so glad I did.


Hey Adrienne, was arthritis a problem for you with UC? If so, did the treatment help you?


----------



## Jajabinks

Wendsjoy said:


> Pmitra, my Crohn's is throughout my small bowel mostly concentrated in the ileum. My worst symptom is pain. I have it in my sides, lower back, stomach, esophagus, tailbone, rectum and even my jaw. I also have joint pain when I am 'flaring' but that seems to be all the time  now a days. My BM's range from 3-12 a day. Urgency is very bad in the mornings. I tend to wake up in the worst pain of the day and most of my BM's occur before early afternoon.  They are bloody and mucousy almost always and very painful. I could write a book but  I have tried everything to relieve the constant inflammation and  pain including SCD diet and HBOT  with acupuncture. The only thing that provides any relief is acupuncture. I have not tried any meds except LDN and entocort.  Neither of which did much. I have such high hopes for this study. I will be devastated if it doesn't work.
> I had a pretty rough day again today. I don't know why I've been up and down so much. I had some more pain and extra BM's. No blood, but very nasty. Not really formed at all. I was so excited to have some initial relief and improvements but after today  I  am scared that the med won't work at all. But maybe it's too early for such big improvements. My body is going to take a while to heal I guess. I read all the posts of those who were in the study and are better now...wondering how long it took to see drastic improvements or if they were more slow and gradual? It has only been a week and tomorrow is another injection day. I am praying so hard that I will improve!
> Trevor, are you experiencing any ups and downs like this?  How are you feeling lately?


Hey Wends! How are you? Are you experiencing any positive results with your body pains?


----------



## Wendsjoy

Jajabinks, yes I have had improvement in my joint pains. I hardly have any anymore  now if everything else would follow along!!


----------



## Jajabinks

Wends that's great! Crohns minus the body pain? I think you are getting somewhere!  One less discomfort for now. I hope things keep going well for you!


----------



## Jajabinks

How long does it take for Qubiologics to contact?


----------



## sir.clausin

Hello everyone!

I will make my space here, since I´ll be participating in the trial on Monday. I am flying over  from Sweden tomorrow to Vancouver. There will be updates everyday, like Trevor and they others have done.

God speed!


----------



## David

That's awesome sir.clausin, I hope it goes well for you.  Either way, thank you for taking part!

I look forward to your updates.


----------



## Poppysocks

I finally got my records in. Hopefully I can speak with the administrator on Monday so I can talk with the Nurse.


----------



## Nosebag

Hi Sir Clausin 

I'm just wondering are you an American or Canadian citizen as I live in Ireland and emailed Qu biologics but they said they can't take international patients at the moment. Congratulations anyway hopefully you have great luck with this treatment.


----------



## sir.clausin

Nosebag: I am a Swedish Citizen and I had my first injection today. I Believe that Qu only have me and a friend of mine from Europe. I can´t speak for Qu, but I am sure you will get a chance now or later on.


----------



## Nosebag

Hi Sir Clausin 

Hopefully I will get into the trial soon. How long do you have to stay in Vancouver? Can you go home to Sweden and self inject?

Thanks for your reply


----------



## SidS

Does SSI cure Crohns or manages it?


----------



## Trevor

Sorry for being flaky! I'm still here. Wedding season kicked into high gear and there's a school strike so work went nuts.

Doing well! Had my last appointment on Monday and I think I have to do labs for another two months but that's it.

Seem to be having more and longer good stretches and fewer bad days. Urgency isn't coming back and is lessening still. BM's are 2-4 a day still and probably less if I wasn't neurotic about it.

Skin just keeps getting better. I've gotta think that it is related. Still some odd/different pains sometimes, but I've decided that it's healing pain.

Still not 'normal' but getting there. 


Still on:

3 caps Mezavant + 1.5 mg pred + .5 g MM (roughly a joint)

and lots of random herbal stuff and probiotics


Was on:

3 caps Mezavant + 15 mg pred + 2 g MM (roughly four joints)

and even more herbal stuff and probiotics


----------



## David

How many more injections do you have Trevor?


----------



## Poppysocks

Looks like my CRP levels are easily high enough for this study. I don't know whether to be excited that I might actually get to participate in this, or feel badly about how bad my blood work and inflammation levels turned out to be.


----------



## bees

Day 86 of 112 for me, been feeling so great I've gone a little nuts and broke my first bone 

Been experimenting with foods I shouldn't eat like red meat and alcohol, and those foods definitely made me a bit sicker so I'm going back to my super healthy diet that helped before I started the treatment.

I'm going to stop eating red meat and dairy for good after reading about MAP & Johne's disease: http://en.wikipedia.org/wiki/Mycobacterium_avium_subspecies_paratuberculosis

I also found a job on my last trip to beautiful Vancouver so I'll be moving there in a week or so.


----------



## Jajabinks

I really like the science behind this research. Hope you are all doing well. I really appreciate the updates on the difference it's made to your arthritis.


----------



## sir.clausin

Well, I just landed in Stockholm, Sweden with the SSI and haven't felt anythinh yet. But today is my fourth injection


----------



## sir.clausin

Great deal Bees! I loved Vancouver. How early did you feel any difference in your health? Please collaborate on your journey!


----------



## rollinstone

Seb, did they for sure give you the drug and not placebo on account of the traveling? Hope you start feeling good soon!


----------



## sir.clausin

Joshuaaa: I don´t know actually. If am an non-responer, then I will be put on the real deal at week8 as I understand.


----------



## Crohn2357

sir.clausin, good luck with the trial.


----------



## MamaHenn

I think I've said this before but I'll say it again.  THANK YOU all for sharing your stories with us.  I'm on this forum b/c I have an 11 year old son who has been diagnosed with Crohn's.  If your willingness to test out these treatment methods paves the way for an easier life for him, well, I will be eternally grateful. Good luck to all of you undergoing these trials and please keep us posted!


----------



## Wendsjoy

Update: I'm in Vancouver for my week 8 visit. I have been deemed a responder and will receive two more months of what I am getting. My lab values have ALL improved. Some more dramatically than others. But it seems that I am on the right track. Will keep you all posted!


----------



## Poppysocks

Wendsjoy said:


> Update: I'm in Vancouver for my week 8 visit. I have been deemed a responder and will receive two more months of what I am getting. My lab values have ALL improved. Some more dramatically than others. But it seems that I am on the right track. Will keep you all posted!


:dance:


----------



## Jajabinks

That's great Wends! How are your bowels, energy, and joints?


----------



## SidS

Is SSI more of a treatment or cure, if you have to get multiple shots?


----------



## rollinstone

Too early to tell yet SidS but there have been people in the compassionate use program that I believe are cured. One of which has been 100% free of disease and off meds for coming up on 4 years. Put it this way, if CD is caused by an infection or immune deficiency (which is looking to be the case as science is slowly showing) then it could indeed be a curative therapy as it addresses the underlying problem.


----------



## Jajabinks

I'm really hoping the nurse calls me soon. I don't think it would be appropriate to call it a cure but it has put people in remission.


----------



## rollinstone

Yeah, it's too early to tell. But it's also largely subjective to beliefs and perception. You can cure a person's cancer but they could still get it again in the future is my point. You can clear a persons infection but that's not to say they might not get the same infection again.. Either way I'm praying this thing is the ticket for IBD, and for interests sake, there were also 2 ppl with UC that are now in 100% on going remission off all meds. That was from the compassionate use program also.


----------



## Poppysocks

I will be talking with the nurse on the week of the 21st, I hope I can get into the trial. I was always diagnosed with Crohns, firstly diagnosed with Crohns, have shown Crohns symptoms, but I fear the one thing that may prevent me from entering is recent colonoscopies from the past 3-4 years have shown me as having chronic colitis. It seems I've had both here and there. I am not sure if I'd be allowed to enter with a previous colitis diagnosis. I haven't had a scope done since that time though, I plan on getting one soon.


----------



## Poppysocks

Joshuaaa said:


> Too early to tell yet SidS but there have been people in the compassionate use program that I believe are cured. One of which has been 100% free of disease and off meds for coming up on 4 years. Put it this way, if CD is caused by an infection or immune deficiency (which is looking to be the case as science is slowly showing) then it could indeed be a curative therapy as it addresses the underlying problem.


I don't think ssi is a curative therapy by itself. In the compassionate use program, the lady I spoke with said 7/10 of patients showed improvement, 4/10 went into remission (but didn't stay in remission), and one patient is still in remission. I think those were the numbers. 

There was a theory I heard recently, that MAP may be acting like a virus, in which, it makes the body more susceptible to certain illnesses, almost like AIDS. MAP lowers you immune systems response to bacteria like Ecoli. 

Correct me if I'm wrong, but isn't that what this vaccine does? It is a harmless injection of dead ecoli which in theory will evoke antibodies to Ecoli in your body that clean out your system of the bad E Coli. 

Now, combine this vaccine, with the MAP vaccine that is showing great promise. Sort of like the MMR vaccine that goes after 3 distinct illnesses. Combine the ssi vaccine with the MAP vaccine, THEN I think we got something pretty potent. Add on top of that dietary changes that limit red meat, milk, and dairy intake and boom. 

This stuff going on right now is so important I don't think it's talked about enough.

I remember like 10 years ago I used to go onto Crohns forums designed for teenagers and people were talking about MAP then. I brushed it off and never bothered to look into it because there was no such thing as a cure for crohns and to even THINK that is heresy. I hope this is not what happens again with map. That is, it gets shoved under the rug for another 10 years and some forget about it, like me.


----------



## sir.clausin

I could not have said it better! actually I will know next week if I am infected by MAP or not.


----------



## Reef08

Poppysocks said:


> I don't think ssi is a curative therapy by itself. In the compassionate use program, the lady I spoke with said 7/10 of patients showed improvement, 4/10 went into remission (but didn't stay in remission), and one patient is still in remission. I think those were the numbers.
> 
> There was a theory I heard recently, that MAP may be acting like a virus, in which, it makes the body more susceptible to certain illnesses, almost like AIDS. MAP lowers you immune systems response to bacteria like Ecoli.
> 
> Correct me if I'm wrong, but isn't that what this vaccine does? It is a harmless injection of dead ecoli which in theory will evoke antibodies to Ecoli in your body that clean out your system of the bad E Coli.
> 
> Now, combine this vaccine, with the MAP vaccine that is showing great promise. Sort of like the MMR vaccine that goes after 3 distinct illnesses. Combine the ssi vaccine with the MAP vaccine, THEN I think we got something pretty potent. Add on top of that dietary changes that limit red meat, milk, and dairy intake and boom.
> 
> This stuff going on right now is so important I don't think it's talked about enough.
> 
> I remember like 10 years ago I used to go onto Crohns forums designed for teenagers and people were talking about MAP then. I brushed it off and never bothered to look into it because there was no such thing as a cure for crohns and to even THINK that is heresy. I hope this is not what happens again with map. That is, it gets shoved under the rug for another 10 years and some forget about it, like me.


Actually all 10 showed improvement, 7 of 10 went into remission, and 4 of those 7 have remained in remission.


----------



## sir.clausin

Did anyone get really tired on the treatment?


----------



## Poppysocks

Reef08 said:


> Actually all 10 showed improvement, 7 of 10 went into remission, and 4 of those 7 have remained in remission.


I stand corrected.


----------



## Nosebag

Hi
Just a question for anyone involved in the trial is there any point in getting the labs done for the trial if your Crohns isn't particularly bad at the minute.

Thanks


----------



## Poppysocks

Updates? I'm assuming no news is good news.


----------



## David

Nosebag said:


> Hi
> Just a question for anyone involved in the trial is there any point in getting the labs done for the trial if your Crohns isn't particularly bad at the minute.
> 
> Thanks


Definitely.


----------



## David

Anyone in the trial have any updates?


----------



## rollinstone

I'm hoping they're all feeling so good they're too busy enjoying life ;p


----------



## sir.clausin

I am certain that I am on the placebo. I have had no reaction what so ever or difference in symptoms.


----------



## rollinstone

Few more weeks bud then you'll get the real deal. Thx for taking part!


----------



## pmitra0123

Hi Guys,

So for me so far, the news is not good.  I am finishing one full month on the open label (meaning I am getting the real med).  I started out with about 9-10 bowel movements a day with blood, mucus, spasm, pain, etc.  My disease is in the colon and it is in its worst state in the left side of the colon - rectum and sigmoid colon.  After one month of SSI, I am pretty much in the same state.  There were a couple of days at week 3 where I was down to 4 bowel movements a day (but still bloody and painful) and I got very excited that I was improving.  But, then I went right back up to 7 and 8 the next day and then 10.  Maybe there is some basic improvement as I go more like 8 times a day now but that is obviously still very bad and probably not improvement.

I can definitely say that I did not get the experience reported in the compassionate trial where people saw full resolution of symptoms within one week of taking the medicine.  I do not understand how these folks all did  so well.  Those results do not seem to have translated in the trial as none of the people on this forum (Wendsjoy, Bees, Treveor) had full resolution of symptoms in one week.  In fact, and correct me if I am wrong Wendsjoy, Bees, and Trevor, but they are still having ups and downs and it took a while to see even the initial improvements.

I am obviously very disappointed as I had very high hopes for this trial after reading about the compassionate use cases.  Unless, I see some miraculous improvements in the next month (which seems doubtful right now as I am still going 8 times a day with blood, mucus and pain), it looks like I will have failed this treatment. =(

Does anyone know of anyone on this medicine that took VERY long to respond to the medicine (i.e. a month) or am I definitely a failure to the treatment?


----------



## Wendsjoy

Hey All, Sorry I have been MIA lately...been really busy with things going on here with my kiddos and stuff. 
I have been doing ok....I still have ups and downs. I will have a few really good days in a row and then a bad one or two. I am consistently at 1 or 2 BMS per day primarily in the morning. I still have stomach pain and bloating occasionally and fatigue although those have all improved. I am in week 10 and still hoping for more improvements. 
pmitra0123, I had a conversation with one of the nurses at the study about the same thing. Even though they called me a responder and my lab work had improved I am ultimately hoping for remission (as we all are, i believe) and to be saved from going on horrible meds like remicade and such, and her reply was that she has seen some people in the study continue to respond after the injections have stopped and some even continue to get better after treatment has ended but not everyone achieves remission. Most do see symptom improvement.
 I agree. It is very disappointing and discouraging to not be in remission when we think we should be based on others accounts of this drug (like the compassionate care people), but try to keep your head up and hang in there. At least you are not worse. :/ it could still work for you. I don't know how those who claim to be better in a week were, but it seems for most that it takes time...I know that for me 4 weeks was not long enough to see any significant improvements.


----------



## Reef08

Well it doesn't seem to be a cure...maybe for the odd person here or there. Not one person on this forum has reached remission. Maybe the dose and the duration of the study need to be increased to reach remission.


----------



## rollinstone

Sorry to hear you guys aren't all 100% that's really hope shattering, but have you had scopes don since to see the how you're doing on the inside? The reason I ask is because I've been told by a few GI that as many as 80% of people with IBD will also have IBS symptoms making it very hard to distinguish when you're in remission (classified by the level of inflammation). Maybe it's worth getting some cal protectin tests done to see what the lvl of inflammation is currently at? Anyway once again thank you all for taking a part in the study and I truly hope things come right for all of you


----------



## Wendsjoy

Joshuaaa said:


> Sorry to hear you guys aren't all 100% that's really hope shattering, but have you had scopes don since to see the how you're doing on the inside? The reason I ask is because I've been told by a few GI that as many as 80% of people with IBD will also have IBS symptoms making it very hard to distinguish when you're in remission (classified by the level of inflammation). Maybe it's worth getting some cal protectin tests done to see what the lvl of inflammation is currently at? Anyway once again thank you all for taking a part in the study and I truly hope things come right for all of you


That was the main lab that had improved for me. My fecal calorotectin went from over 800 to 311  a year ago it was upwards of 1200. 
I'm not denying that I am improving, just not as much or as consistently as I expected. It's still better than any other med I have tried and is keeping me from high steroids and immuno suppressants which is my ultimate goal here. Sometimes I needs to re-evaluate to put things into a more 'realistic perspective' ya know?


----------



## rollinstone

I hear ya, still really disappointing that you aren't 100% there yet, do you know if they're using the same doses as the compassionate program?


----------



## Wendsjoy

I'm not sure about the doses. They are based on individual reactions so everyone's is probably different. I do think I remember hearing that Tyler Wilson started out at a much lower dose than we did. Not sure tho.


----------



## pmitra0123

Ya the doses are not the prob. - I have taken high doses and still no response.  Would like to hear others experiences and thoughts


----------



## David

pmitra0123 said:


> I am obviously very disappointed as I had very high hopes for this trial after reading about the compassionate use cases.  Unless, I see some miraculous improvements in the next month (which seems doubtful right now as I am still going 8 times a day with blood, mucus and pain), it looks like I will have failed this treatment. =(
> 
> Does anyone know of anyone on this medicine that took VERY long to respond to the medicine (i.e. a month) or am I definitely a failure to the treatment?


Bummer   I wish you were doing better.  That must be really frustrating.  Hopefully you start improving.  If not, as hard as it has been, thank you so much for taking part in the trial.  It's important that these studies be done.


----------



## David

pmitra0123 said:


> Ya the doses are not the prob. - I have taken high doses and still no response.  Would like to hear others experiences and thoughts


When you say you've taken high doses, you've tried higher than the prescribed amount?


----------



## Poppysocks

pmitra,

the vaccine might not be working because of where your disease is located. You might have something different than everyone else participating.


----------



## David

Poppysocks said:


> pmitra,
> 
> the vaccine might not be working because of where your disease is located. You might have something different than everyone else participating.


That's certainly possible.  I've always suspected that Crohn's disease is caused by someone different factors for different people.  Time will tell on that I guess.

I hope when they do the data analysis that they are able to break the data down further into people that have ileal disease, disease of both the ileum and large intestine, and Crohn's colitis.


----------



## rollinstone

Lots of different variables.. Could be that your disease has a different cause than macrophage dysfunction, maybe it stems from a bacterial disbiosis, maybe it's MAP, and then plz forgive me for the silly question, but are have you finished the 8 weeks
of potential placebo and know your on the open label drug? Either way hope you get some improvement soon.


----------



## Wendsjoy

I have thought that for soooo long! And no dr will listen to me. My Crohn's is so different than anyone else's. Nothing works for me. My trigger was an iron infusion that a dr gave me that I didn't need. It caused me to have iron overload and that deteriorated my small bowel ultimately causing Crohn's. My mother had severe UC so I know that I am genetically predisposed to having gut issues and that is where my problems are. Plus I now have fissures and everything else with Crohn's including reflux and joint pain...etc etc. I have tried so many thing including various diets and probiotics and hyperbaric but my body doesn't respond to any of it or I get worse. I can't figure out what is causing the Crohn's in the first  place or if my intestines were so damaged from the iron that they just can't heal. I don't know. It's so frustrating. I am suffering constantly and there is no dr that will listen. They all just push prednisone or remicade on me and I refuse to put those chemicals in my body. I went from a healthy mother and wife who ran marathons to a skinny rake who can barely move or eat. It's sad really. The fact that there are no treatments for this disease that aren't terribly detrimental to ones overall health otherwise or that just bandage the symptoms is a tragedy. 
Sorry for venting. Just feeling discouraged and depressed tonight I guess. Haven't been feeling that great lately. I'm in week 11 now. No better than the last post.


----------



## David

Wendsjoy, iron inhibits the absorption of magnesium.  My theory for the cause of some Crohn's disease actually starts with magnesium deficiency.  Have you ever tried a magnesium supplement?


----------



## rollinstone

What's your diet like wendsjoy? I'm sure you've already tried scd and paleo but if you haven't they can be pretty effective alongside medication, otherwise other options I would look into if I was in the US are cannabis oil, FMT, or if you can find a doc maybe anti-map therapy. But don't give up just yet, you've obviously improved with the SSI especially considering your cal protectin drop, so maybe you just need a few more tweaks. Bless.


----------



## rollinstone

Wonder how Trevor is going?


----------



## pmitra0123

ive taken doses that are high but not more than the prescribed - we take doses based on our reaction.  

poppysocks - maybe but unlikely. my disease is located more in the left side of the colon - originally I was diagnosed as ulcerative colitis but then they discovered a granuloma and said it was crohns.  The trial doctor told me the location of my disease doesn't matter because the medicine doesn't work based on location - it works to remove cells that have necrotized and burst and the innate immune system hasnt' cleared them out which then sparks inflammation.  The recruitment of the innate immune system to the colon to clear out the inflammation signals should not be affected on whether the crohns is in the descending colon or the ascending colon, etc. Also, I was told there was 2 uc patients on the compassionate trial with rectal disease who did better as a result of the ssi- remission I think.  I don't know - it seems to me that the compassionate trial results were amazingly good - and the results for me and others in this trial are no where near those amazingly good compassionate trial results - those people saw all symptoms go away in 1-2 weeks.


----------



## Wendsjoy

David, I do take magnesium. I was considering taking a higher dose but I'm afraid of over dosing on it. Is there an amount that is recommended?
Joshuaa, I have tried SCD and paleo. I was on SCD for almost a whole year. Did it completely. No cheating and tried their supplements and everything they recommend as well. It did nothing except cause further weight loss for me. Paleo helps me feel more energized but does nothing for the Crohn's symptoms. I have also tried the makers diet, that was expensive to do and did nothing, actually made me worse. Too much fiber I think. I also have tried fecal transplant and glutathione infusions with hyperbaric therapy. Neither of which did anything at all.  I tried upper cervical chiropractic too. That helped the joint pains but not much else. I was recently looking Into cannabis. Do you really think it's worth it? Any idea where to get it from? I was also thinking of trying essentials oils or camels milk. Any ideas on those? What is fmt? 
The one thing that helps me feel better sometimes is accupuncture. I have a fantastic acupuncturist who knows just where to treat me to help. But money is toght now after all these treatments that didn't work and that's another expensive one!


----------



## rollinstone

FMT is fecal transplant, that sucks it didn't help you, I definitely do think cannabis oil is worth a try, there's a medical marijuana thread on here, people swear by it. Also I just wanna say, don't be scared to give remicade a go if you have to, it's helped ALOT of people get into remission.. Also, look into vitamin D supplementation, very important for ppl suffering w CD. Hang in there things will get better! And also look into anti-map if you really don't think you're getting better, maybe Thatl be your ticket.


----------



## David

Wendsjoy said:


> David, I do take magnesium. I was considering taking a higher dose but I'm afraid of over dosing on it. Is there an amount that is recommended?


What kind of magnesium do you take?  Oxide?  Citrate?  Glycinate?  Something else?


----------



## Poppysocks

Wendsjoy said:


> David, I do take magnesium. I was considering taking a higher dose but I'm afraid of over dosing on it. Is there an amount that is recommended?
> Joshuaa, I have tried SCD and paleo. I was on SCD for almost a whole year. Did it completely. No cheating and tried their supplements and everything they recommend as well. It did nothing except cause further weight loss for me. Paleo helps me feel more energized but does nothing for the Crohn's symptoms. I have also tried the makers diet, that was expensive to do and did nothing, actually made me worse. Too much fiber I think. I also have tried fecal transplant and glutathione infusions with hyperbaric therapy. Neither of which did anything at all.  I tried upper cervical chiropractic too. That helped the joint pains but not much else. I was recently looking Into cannabis. Do you really think it's worth it? Any idea where to get it from? I was also thinking of trying essentials oils or camels milk. Any ideas on those? What is fmt?
> The one thing that helps me feel better sometimes is accupuncture. I have a fantastic acupuncturist who knows just where to treat me to help. But money is toght now after all these treatments that didn't work and that's another expensive one!


Maybe combining the paleo diet with your current SSi therapy would be a good idea? I think when people get bad disease, they have to fight the illness from many different directions. I think people with Crohns should be trying the very hardest to continually eat as healthy as possible. 

I wouldn't be touching cheeseburgers or anything like that, I think you mentioned you ate one earlier in the thread.


----------



## David

Poppysocks said:


> Maybe combining the paleo diet with your current SSi therapy would be a good idea? I think when people get bad disease, they have to fight the illness from many different directions. I think people with Crohns should be trying the very hardest to continually eat as healthy as possible.
> 
> I wouldn't be touching cheeseburgers or anything like that, I think you mentioned you ate one earlier in the thread.


Agreed.  SSI isn't a miracle cure, it is a potential treatment option and everything from dose to duration still needs to be worked out.  We're very early in the evaluation phase of this potential treatment.  If this phase I/II trial shows promise (which I am about 95% sure it will) then the phase III trial will be much more extensive and likely test different dosages, durations, and a host of other variables.  

I understand the desire for people taking this treatment to dive into eating their favorite spicy chili and a salad week one or two.  But the thing is, due to the nature of Crohn's disease and the damage it does to the digestive tract, even if the disease was shut off day one, it could literally take months for the digestive tract to heal in a manner that allows trigger foods to be eaten again. Heck, it may be that some trigger foods can never be eaten as we don't yet understand how Crohn's affects the various body systems.

The data I'm seeing from everyone except pmitra is extremely promising.  Reduced bowel movements, drastically improved labs, etc all point to a treatment that is efficacious.  But the reality is, you all still have Crohn's.  SSI is not a cure and until you are in deep, stable remission with a fully healed intestinal mucous layer, I strongly suggest eating like you're in an active flare.  This holds true for SSI, Remicade, 6mp, or any other treatment out there.


----------



## pmitra0123

Good point David - I do admit that I have not been the healthiest in my choices of food but still I'd like to have seen at least some minor improvements by now.  Not too sure about your 95% confidence that SSI will succeed.  

Wendsjoy - I am sad to see you are having bad days.  I was hoping at your late stage in the treatment, you would be much better.  =( Hang in there - hoping we both show miraculous improvement in our final time in the trial.

How's Trevor doing? And bees? Are you guys still up and down?


----------



## Wendsjoy

Thanks for the info everyone. I am feeling encouraged  I appreciate you all more than you know! 
David, I am not at home right now to check but I believe I take magnesium citrate. I agree with you too about the SSI. I think it's a wonderful option. It has improved some of my symptoms and you can not deny the lab work! It was amazing to see. I'm thinking my symptoms will follow suit, hopefully soon! I am excited to see how many people this med will help without all the detrimental effects of the other options. 
Jashuaa, thanks for the suggestions! I think I will try the cbd. I'll let you know how it works. 
Poppy, I do eat healthy. I try to stick to paleo. The cheeseburger was a one time thing. Haha I have pretty much determined that foods are not my trigger. Certainly there are foods that don't agree with me, but that goes for anyone. I am still gluten and dairy free and I had my blood tested for food sensitivities so I stay away from a those as well. I like to think of my diet as modified paleo. 
Pmitra, I think you'll start to feel improvements soon. It took me a while to feel anything from this. Your lab work at the end may show improvement too.


----------



## David

pmitra0123 said:


> Good point David - I do admit that I have not been the healthiest in my choices of food but still I'd like to have seen at least some minor improvements by now.  Not too sure about your 95% confidence that SSI will succeed.


I would have liked to see some improvements in you too   I'm frustrated for you, so I can only imagine how you're feeling.  

*hugs*

As for my 95% confidence, something I very rarely discuss on this forum is how the medications used to treat Crohn's disease get approved.  As they go through clinical trials, often the endpoint to judge success is a certain reduction in the CDAI (Crohn's Disease Activity Index).  The endpoints aren't deep stable remission, but more a reduction in symptoms.  Some of the data is pretty bad overall but because of the reduction in CDAI, it is statistically significant enough where the medication is approved.  I suspect that SSI is going to blow the results of some other already approved treatments out of the water based upon what we've seen thus far.


----------



## David

Wendsjoy said:


> Thanks for the info everyone. I am feeling encouraged  I appreciate you all more than you know!
> David, I am not at home right now to check but I believe I take magnesium citrate.


When you're able, will you please check the back of the bottle and see what percentage of the "citrate" is actually citrate and what percentage is oxide?  A LOT of supplement manufacturers are actually quite unethical and call it citrate when the majority is oxide.

And how much do you take per day?


----------



## pmitra0123

David - how do you know the CDAI is so much better for people?  Wendsjoy has better fecalprotectin, but that's not CDAI.  Fecalcalprotectin can go up and down randomly.


----------



## Wendsjoy

David, I take 250mg of magnesium oxide


----------



## David

pmitra0123 said:


> David - how do you know the CDAI is so much better for people?  Wendsjoy has better fecalprotectin, but that's not CDAI.  Fecalcalprotectin can go up and down randomly.


Here's an example of what goes into the CDAI calculation: http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0048967/

Would wendsjoy show a significant reduction?  I'm not sure.  Would Trevor and Bees?  Definitely.

Keep in mind I'm not sure what endpoint is being used for SSI.  But if this was a drug being tested by big pharma with CDAI reduction as the endpoint, I suspect you'd have some very excited executives.


----------



## David

Wendsjoy said:


> David, I take 250mg of magnesium oxide


I suspected as much.  Magnesium oxide is by far the worst absorbed form of magnesium and with your symptoms, I suspect you may be losing more Mg than you take in.  

I suggest trying this magnesium: http://www.amazon.com/Designs-Health-Magnesium-Glycinate-Capsules/dp/B000FGWBK6/

I'd take one in the morning and one in the evening.  Don't take it with iron if you're taking an iron supplement.  If after 10 days you feel fine on that dose, I'd kick it up to two in the morning and one in the evening.  After 10 days you are still good, kick it up to 2 in the morning and 2 in the evening.

As always, checking with your doctor before following the advice of some guy on the internet is a good idea


----------



## Wendsjoy

Thanks David  I will definitely bring it up at my next appointment. Thanks for the info. I had no idea about that. I knew that I needed magnesium, thought I was getting enough! 

also, to weigh in on the cdai discussion. At my last appt with the study dr's my cdai score had improved. They base their decisions on symptom improvement and lab work. So both of mine were at least improved slightly so my cdai score was within the responder range. If that makes sense.


----------



## Trevor

Joshuaaa said:


> I'm hoping they're all feeling so good they're too busy enjoying life ;p


Almost :lol:

Hey guys! Took a bit of a break from life the last couple weeks since work got quiet, finally. Really needed it, it's been a long/emotional few months.

But...

*I'm feeling GREAT !!!*

We're at week 20-ish (I think) since I started trial and about 4 weeks since my final clinic visit and yesterday was far and away my best day. Today seems to be going well, too. Friday was a 'bad' day but even the bad days are hardly bad (by Crohnnie standards).

2-3 BM's is pretty standard, still, but I'd bet money that'll change eventually, too. Urgency is still improving. Skin/joints/hair/nails still improving. Energy WAY up. I feel like I'm 26 again (which I am...) rather than 56.

:yoshijumpjoy: :yoshijumpjoy: :yoshijumpjoy:

Fingers crossed that it sticks. Really focusing on my sleep/diet/exercise/sun/stress the next little bit.


Edit:

Just reading back and trying to catch up on all the action.

Magnesium! SO on-board with this. I've been doing topical (gel/oil and epsom salt baths) and supplemental magnesium (MSM) for months and as far as supplements go it's the one I feel makes the most difference, for me.

If stress is an issue (ha) I do find it very calming and relaxing, too.


----------



## pmitra0123

Good to hear Trevor that you are doing well - question - when did you start feeling improvements? what week? I am at week 5 and a half with no improvements - do you think I am a fail? 

Also, how have your fecal calprotectin numbers fared/improved?


----------



## bees

I've been super busy, I moved to Vancouver and started a new job this month, it's nice to be able to work again!

I'm on week 16, I was feeling fantastic a few months ago and consumed too much alcohol and junk food and gave myself a flareup, starting to feel better again now that I'm back to a healthier diet.


----------



## Lady Organic

pmitra0123 said:


> Hi Guys,
> 
> So for me so far, the news is not good.  I am finishing one full month on the open label (meaning I am getting the real med).  I started out with about 9-10 bowel movements a day with blood, mucus, spasm, pain, etc.  My disease is in the colon and it is in its worst state in the left side of the colon - rectum and sigmoid colon.  After one month of SSI, I am pretty much in the same state.  There were a couple of days at week 3 where I was down to 4 bowel movements a day (but still bloody and painful) and I got very excited that I was improving.  But, then I went right back up to 7 and 8 the next day and then 10.  Maybe there is some basic improvement as I go more like 8 times a day now but that is obviously still very bad and probably not improvement.
> 
> I can definitely say that I did not get the experience reported in the compassionate trial where people saw full resolution of symptoms within one week of taking the medicine.  I do not understand how these folks all did  so well.  Those results do not seem to have translated in the trial as none of the people on this forum (Wendsjoy, Bees, Treveor) had full resolution of symptoms in one week.  In fact, and correct me if I am wrong Wendsjoy, Bees, and Trevor, but they are still having ups and downs and it took a while to see even the initial improvements.
> 
> I am obviously very disappointed as I had very high hopes for this trial after reading about the compassionate use cases.  Unless, I see some miraculous improvements in the next month (which seems doubtful right now as I am still going 8 times a day with blood, mucus and pain), it looks like I will have failed this treatment. =(
> 
> Does anyone know of anyone on this medicine that took VERY long to respond to the medicine (i.e. a month) or am I definitely a failure to the treatment?


Im so sad to ear that. I have same disease location as you so I know excatly what your symptoms are. Are you taking other medications along the SSI? Are you allowed Pred?


----------



## Pondle

Provided all goes nicely, how long until this treatment is available?


----------



## pmitra0123

Lady Organic - nope just the SSI mainly.  What medicines do you take? Anything work? Do you have Crohns or UC? My disease is heavily located in the left side and was always considered UC but then they found a granuloma and changed it to Crohns.  How are you holding up overall?


----------



## Trevor

pmitra0123 said:


> Good to hear Trevor that you are doing well - question - when did you start feeling improvements? what week? I am at week 5 and a half with no improvements - do you think I am a fail?
> 
> Also, how have your fecal calprotectin numbers fared/improved?



I haven't gotten my labs yet but I've got a meeting with my GI in August and I'll stop by and say hello to the trial nurse and see if I can get them. By then I should have all the labs up to week 20 + the ones to get into the trial. Should make a nice graph :ycool:

As far as when I felt better, well, really only this week have I started having days that feel like what I would consider remission. I think I really started to feel consistently better around week 6-7 on the open-label, though. The first month was really up and down and I'd say I actually felt worse than I had the previous month. The first two weeks were especially not awesome.

I wouldn't give up yet 

A Paleo-ish diet, magnesium, fermented foods and probiotics + sun, sleep, less stress and more exercise. Pump up that immune system!


----------



## Trevor

Pondle said:


> Provided all goes nicely, how long until this treatment is available?


Anywhere from 2016 to 2018 if things go reasonably smoothly, was my understanding. I think that was in reference to Canada, though.


----------



## David

Trevor said:


> A Paleo-ish diet, magnesium, fermented foods and probiotics + sun, sleep, less stress and more exercise. Pump up that immune system!


You're a wise man Trevor.  I agree about the vitamin D (sun) in addition to the magnesium.  As, in theory, SSI are improving the immune response, it makes sense to make sure that two of the most important nutrient components for a healthy immune system are in ample supply.


----------



## Lady Organic

Trevor said:


> A Paleo-ish diet, magnesium, fermented foods and probiotics + sun, sleep, less stress and more exercise. Pump up that immune system!


Hi Trevor, when did you start your diet?


----------



## Trevor

I've been doing Paleo / GAPS / SCD for a couple years now, with various amounts of success and failure.

I did really tighten things up for a few months. December through probably March. Less carbs, more intermittent fasting.

My diet on a daily basis is, at the moment, standard Paleo with some rice and butter/heavy cream/yogurt.

Started to shy away from focusing on what not to eat and more on how to maximize my nutritional intake. Better quality protein, more local fruits and veggies when I can and better, more dish-appropriate fats. Lots of organ meats and homemade stock and soup.

Maybe once every week or ten days I'll have something 'bad'. Compared to my diet three or fours years ago, miles better.


----------



## Trevor

David said:


> You're a wise man Trevor.  I agree about the vitamin D (sun) in addition to the magnesium.  As, in theory, SSI are improving the immune response, it makes sense to make sure that two of the most important nutrient components for a healthy immune system are in ample supply.


My brain exploded when I learned that vitamin D is actually a class of steroid.

I have been taking fermented cod liver oil every morning and then vitamin D drops a couple of nights a week, as well.


----------



## Trevor

Gorgeous BC day long-weekend! Which I am spending at work...

I did go away for a few days. It's nice not to feel trapped at home/work. Still feeling very good to great depending on the day. Bad days are still getting better.

2 - 3 BM's most days still. A bad day is 4. Good day 1 or 2. Mostly just checking in  everything still going A-OK.

Just on Mezavant now, as far as prescriptions.


----------



## David

You're completely off the prednisone Trevor?  Congratulations!


----------



## Trevor

Thanks! 60 mg to 0 in just 8 short months. Ha.

It's been so little for so long but it does feel nice to put the half-full vat of Pred tabs they gave me under the sink.

Never again, lets hope.


----------



## InkyStinky

Hi Trevor! Hooray for no more pred!!!!

I've been reading up on the SSI trial and I am so excited about it! If I were flaring I'd try everything feasible to get into this trial --- here's hoping this is a long-term solution for you!!!


----------



## Trevor

InkyStinky said:


> Hi Trevor! Hooray for no more pred!!!!
> 
> I've been reading up on the SSI trial and I am so excited about it! If I were flaring I'd try everything feasible to get into this trial --- here's hoping this is a long-term solution for you!!!



Thanks! Hopefully it'll be out in the world soon.


----------



## Trevor

Had dinner at a friends house that's about a 15-minute drive from home last night.

Other than the gf, who lives 2 minutes from my place, I haven't had dinner out at a resturant or someone's house (not even a family dinner or my parents place) for 9 months.

So that was nice 


On the other side, super arthritic yesterday. Could be nothing. Could be the weather. Doesn't seem to be an issue this morning.


----------



## Nosebag

Hi Trevor

That's great hopefully things only get better. It gives me great hope to hear that you are improving all the time.
Thanks for Jeeping us informed.


----------



## Nosebag

Ha sorry keeping stupid auto correct.


----------



## Trevor

Thanks! I'm glad it's useful. 

I'll do my best to keep things updated once or twice a week until the 1 year mark, at least.


----------



## Nosebag

Thanks again Trevor I practically stalk this thread to see how you and the others are doing. I'm trying to get involved in the trial but I live in Ireland and will have to stop remicade for sixty days but hopefully I won't get the placebo if I do take part.
Good luck


----------



## Wendsjoy

Update from me: I am starting week 14 today. I am feeling better than I was last time I updated. I have less urgency and my BM's are getting more formed. I am at 1-3 per day (usually at 1 in the morning) I have still been pretty tired but I have a horrible head cold so that prob has something to do with the fatigue. I also wanted to point out that I haven't had a cold like this since before my diagnosis. I think that is a good thing because whenever I got 'sick' before if just have horrible diarrhea and Crohn's symptoms. Maybe my bowel isn't my weakest spot anymore?? 
I usually have good days and bad. The bad aren't as bad anymore but I still have them. I just get so bloated and crampy and tired...if I could just stay on 'good days' I'd be great!


----------



## Trevor

Wendsjoy said:


> Update from me: I am starting week 14 today. I am feeling better than I was last time I updated. I have less urgency and my BM's are getting more formed. I am at 1-3 per day (usually at 1 in the morning) I have still been pretty tired but I have a horrible head cold so that prob has something to do with the fatigue. I also wanted to point out that I haven't had a cold like this since before my diagnosis. I think that is a good thing because whenever I got 'sick' before if just have horrible diarrhea and Crohn's symptoms. Maybe my bowel isn't my weakest spot anymore??
> I usually have good days and bad. The bad aren't as bad anymore but I still have them. I just get so bloated and crampy and tired...if I could just stay on 'good days' I'd be great!


That cold thing, that sounds super promising


----------



## David

Nosebag said:


> Thanks again Trevor I practically stalk this thread to see how you and the others are doing. I'm trying to get involved in the trial but I live in Ireland and will have to stop remicade for sixty days but hopefully I won't get the placebo if I do take part.
> Good luck


Are you responding well to Remicade?


----------



## David

Wendsjoy said:


> I just get so bloated and crampy and tired...if I could just stay on 'good days' I'd be great!


Is the bloating a new symptom or something you've had for awhile?  How about the tiredness?  When was the last time you had your vitamin B12 level tested?


----------



## Wendsjoy

David said:


> Is the bloating a new symptom or something you've had for awhile?  How about the tiredness?  When was the last time you had your vitamin B12 level tested?


No. It's not. I've had issues with that stuff since diagnosis. The tiredness has been getting worse and worse but isn't as bad since I started the SSI. My vit B12 was checked about a year ago and was normal. I actually had b12 njections that I was doing and had an allergic reaction from them so I had to stop but my levels were normal anyway.


----------



## rollinstone

Wends, I know you mentioned you'd tried diets in the past, but maybe give one a go for a week or two and keep a food journal, i just discovered an awesome recipe for rice, you cook it in scd chicken stock, dash of olive oil, teaspoon of salt n pepper, some black beans, lil bit of ginger, it's sooo Tasty and really easy to digest, I also get painful bloating but iv been eating this past two days and it's stopped.. Just a thought. Bless ya xo


----------



## Trevor

+1 to anything with ginger in it - I make ginger tea periodically and it's almost as good as MM at settling my stomach.

Been doing 'gingerade kombucha' a bit lately, that stuff is pretty great.

Arthritis seems to have gone away again (storm rolled in so I am thinking just the weather) and today is almost toooo good...

I'm getting suspicious, haha.


----------



## Nosebag

Hi Dave

I have been on remicade since February as I started back on imuran last November along with steroids but actually got worse. I refused to take remicade but in the end I had no choice the pain diarrhoea and fact that I couldn't feed or look after my baby made me cave. I wasn't living to be honest. I get infusions every eight weeks and 100mg of imuran daily along with imodium and bile acid sequesterants. I am grateful for remicade giving me my life back but I still feel like I'm ready to flare at any moment even though I eat plain foods and take all these horrible meds. I really want to have a second child but realistically can't see it happening with how I feel. I am also terrified of what might happen as I had two operations during my pregnancy and my Crohns which for the last twenry years remained in my sum spread to my colon.

Sorry for life story
Nosebag


----------



## David

You have nothing to apologize for, I appreciate you sharing!

Obviously I want this trial to be filled up.  In your case though, I'm not 100% sure that it is the best choice at present.  While I very much believe in this treatment:

1.  It is experimental
2.  When you're done with the trial, you're done.  They don't send you home with more vials to cover you for the next 2 years.

The problem with stopping Remicade is that is when antibodies are often formed.  When your body begins to make antibodies, the biologic starts to not work and/or you get some side effects.  As such, my concern is that you stop Remicade, take the SSI and if at some point you flare again before SSI is available as a treatment, Remicade is no longer effective for you.  

I'm not saying don't take part in the SSI trial, but this is definitely something to discuss with your doctor and family.


----------



## Nosebag

Hi Dave

I haven't got the labs done yet to see if I am actually eligible for the trial so its not for definite but I understand what your saying. I have discussed coming off remicade before with my doctor as the original plan was for me to just get three shots of remicade because I was so against taking it in the first place. I was told that if I still take imuran I shouldn't build up antibodies to remicade. My fear would be  after sixty days that the treatment wouldn't work or I get the placebo. I can stop participating in the trial at anytime but I just feel like its worth taking a chance if it alows me to have a baby or to


----------



## Nosebag

take just  one medication.
Thanks again Dave


----------



## Lady Organic

I think you have to be 2 months off a biologics to participate in the trial and agree not to be pregnant during the whole trial.


----------



## Poppysocks

David said:


> You have nothing to apologize for, I appreciate you sharing!
> 
> Obviously I want this trial to be filled up.  In your case though, I'm not 100% sure that it is the best choice at present.  While I very much believe in this treatment:
> 
> 1.  It is experimental
> 2.  When you're done with the trial, you're done.  They don't send you home with more vials to cover you for the next 2 years.
> 
> The problem with stopping Remicade is that is when antibodies are often formed.  When your body begins to make antibodies, the biologic starts to not work and/or you get some side effects.  As such, my concern is that you stop Remicade, take the SSI and if at some point you flare again before SSI is available as a treatment, Remicade is no longer effective for you.
> 
> I'm not saying don't take part in the SSI trial, but this is definitely something to discuss with your doctor and family.


This is why I am second guessing my self on starting the trial. Even if it does work, it's stopped working for most people eventually. Once that's over you're done, until it's available to everyone.


----------



## David

Poppysocks said:


> This is why I am second guessing my self on starting the trial. Even if it does work, it's stopped working for most people eventually. Once that's over you're done, until it's available to everyone.


Are you on a biologic that is working well for you?


----------



## Poppysocks

David said:


> Are you on a biologic that is working well for you?


I wouldn't categorize it as "well". But it helps play a part in keeping me from getting incredibly sick. I don't think that should be anybody's goal though, when dealing with this illness.

I broke out in Shingles at the end of December 2013, obviously due to the high doses of Remicade, and have been trying desperately to get off it since then. 

I would love to try ssi, but 

1) Like you said, you don't get to continue treatment, it eventually stops.

2) might get placebo, might have to go 4 months without remicade. 

3) Just found out today I have a pretty bad rectal stricture, so I can't really afford to be a guinea pig. 

Now, if the vaccine was approved and I knew what I was getting, and could continue treatment and could make an attempt that way, I would, without a doubt give it a shot. 

I'm wondering how long this will take to make it to the market, if it ever does, and if it ends up being incredibly expensive or not, I bet it wouldn't be covered by insurance.


----------



## David

You've already tried Cimzia and Humira?

Did they tell you if the rectal stricture is from active inflammation or scar tissue?

And if/when SSI gets approved as a treatment, as it is going through the proper clinical trial processes, insurance companies should pay for it.


----------



## Poppysocks

David said:


> You've already tried Cimzia and Humira?
> 
> Did they tell you if the rectal stricture is from active inflammation or scar tissue?
> 
> And if/when SSI gets approved as a treatment, as it is going through the proper clinical trial processes, insurance companies should pay for it.


I just had the colonoscopy done today so I didn't get that information. He could only make it a few a couple inches before he had to stop. I guess it's bad enough that he set up an appointment with a colo-rectal surgeon, so, can't be good. He sent out biopsy results too. I suspect it's probably scarring, as I haven't had formed BM's in a very, very long time.

I've tried Humira but didn't really think it was as effective as Remicade. I may not have given it a fair shot though. Never tried cimzia. I've also been on mesalamine enemas the last month and a half which have been amazing I've put on about 10 pounds since starting them. BM's are a lot more formed, although obviously, from the strictures, they are far from perfect shape.

There's also the anti-MAP study going on. I've contacted them and there's an office in clearwater, about 2 hours from where I live that is participating in the study. Again, I'd definitely think of this as an option if it weren't for the fact that I might get the placebo. With that study, there is no open label. They give you either the real stuff or placebo and if neither work you can discontinue the study.


----------



## David

You do understand that you DO get the real SSI at a certain point even if you get the placebo initially, correct?

If I was in your place:

1.  If the stricture was due to inflammation, I would try SSI before I let them do surgery and I would be willing to go off Remicade to do that.  If you have active inflammation with Remicade, in my opinion it is not working well enough and it is worth trying something else.

2.  If the stricture was due to scarring and I had active inflammation elsewhere, I would do SSI before the surgery in an attempt to reach remission as that often leads to better surgical outcomes.  I would be willing to go off Remicade due to that.

3.  If the stricture was due to scarring from old inflammation but I was in remission from the Remicade otherwise, I might just stick with the Remicade.

That's just me though.  We each have to weigh our own countless variables and hopefully we have doctors that can help us do that.


----------



## Poppysocks

David said:


> You do understand that you DO get the real SSI at a certain point even if you get the placebo initially, correct?


Yes, I understand. Just a little flustered after the colonoscopy today.


> If I was in your place:
> 
> 1.  If the stricture was due to inflammation, I would try SSI before I let them do surgery and I would be willing to go off Remicade to do that.  If you have active inflammation with Remicade, in my opinion it is not working well enough and it is worth trying something else.
> 
> 2.  If the stricture was due to scarring and I had active inflammation elsewhere, I would do SSI before the surgery in an attempt to reach remission as that often leads to better surgical outcomes.  I would be willing to go off Remicade due to that.
> 
> 3.  If the stricture was due to scarring from old inflammation but I was in remission from the Remicade otherwise, I might just stick with the Remicade.
> 
> That's just me though.  We each have to weigh our own countless variables and hopefully we have doctors that can help us do that.


Thanks David. Your words are heeded. 

I do have active inflammation, my current CRP is around 4.7 and my ESR around 48. I don't believe I am in remission even while on the Remi. To be honest I have no idea what remission even feels like, my BM's have been unformed for so long. I guess my appointment with the surgeon in the near future and my biopsy results will determine whether the stricture is from active inflammation or old inflammation that scarred.

Qu has received my medical records and Doctor Bressler is looking through them to see if I will be a good patient for the study. I should be informed shortly on whether they want to proceed with me as a patient.


----------



## David

Please keep us updated with what Qu and your colorectal surgeon say.


----------



## sir.clausin

Ok, so I am heading over to Vancouver for a second visit. This time I will get the real deal, so typical that I got the "sugar water" it has made me crohns worse, being out any medication for this time. Anyhow, let´s see how this will get.


----------



## worriedboy

Good luck, fingers crossed...


----------



## Lady Organic

I pray for you and for all of us that it will work and fast so your CD doesnt keep aggravating. Thanks for participating.


----------



## Trevor

Things are still good/improving here sir.clausin - I am hoping the unpleasantness of the placebo will be as worth it for you as it has been for me!


----------



## rollinstone

How you doin seb?


----------



## sir.clausin

Just woke up, last day was my first day of the open label, and I think I am on the actual stuff, not the placebo!  Happy times


----------



## anti_map

When will this vaccine be available?


----------



## loveleen garg

Hey.... is there any improvement?


----------



## Trevor

Just got home from an epic weekend of wedding photography ! It's been almost a year since I shot a wedding and I haven't gone and done any events since November. It was a huge milestone for me mentally and I am super pleased to report that today may be my best day in living memory.

So happy to hear you're on the right track Sir.Clausin !!!


----------



## rollinstone

Man, so happy to hear that! Can't wait for this trial to be spread around the globe, I think they're on to a winner! How are the rest of you going? Wends, bees etc


----------



## David

anti_map said:


> When will this vaccine be available?


This treatment won't be available for those outside of the clinical trial for at least a couple years.  They have to finish this trial, do a phase III trial, then get final approval if the data supports getting approved which hopefully it will.


----------



## tzvia

I can't wait until it's available.  I tried to to get into the trial but I was rejected because my stricture was too bad.  It was sooooo disappointing.  Now I'm on humira but it doesn't seem to be doing much.


----------



## David

How's everyone feeling?  Any updates?


----------



## cicconeca

Hi all, 

Thought I would share my story.  I was diagnosed with CD in 2012 during my last year of medical residency.  I had learned about IBD during med school and thought it was mainly just some abd pain and loose stools.  Boy was I wrong.  I've suffered so much with flu like symptoms and severe fatigue.  I tried controlling it with prednisone but the side effects were just about as bad as the disease at times.  I refused biologics or immunosuppressants.  This lead me to the SSI vaccine trial.  I was in the placebo group for the first phase and have now been on the real thing for about 6 weeks.  I've noticed some improvement in my symptoms especially the pain and energy reserve.  I used to have a constant knot in my right lower quadrant of my abd that is mostly gone.  My stools have definitely become denser and more formed.  I still wouldn't qualify them as normal but improved.  I still have some burning with defecation occasionally.  I have gained almost a pound each of the past 6 weeks.  

I'm grateful I stumbled on crohns forum.  Look forward to hearing others stories and updates on their progress as well.  Thanks to all of you who are also participating.  I think this will be revolutionary and certainly better than the current "treatments" being offered.


----------



## David

Thanks for taking the time to share your story cicconeca!  Out of curiosity, why did you decide to refuse immunosuppressants and biologics?  I hope your symptoms continue to improve and you are able to reach deep, stable remission!


----------



## cicconeca

Hi David,

Thanks for your reply.

To be honest, some of it was timing.  I started looking for alternatives to the standard treatments.  I held out and got enrolled in the study.  

My main concern with Imuran/6-MP was the nearly fourfold increased risk of lymphoma, at least in preliminary studies.

I refused biologics with the concern of drug-induced lupus and worried about decreased efficacy over time.

If SSI had not been available in all reality I may have had no choice but to start other traditional meds.

The med school I attended always encouraged us to question the status quo and to look for more natural therapies with less side effects and lower risk profile.  To me SSI therapy is better in so many ways.  It's definitely not an over night cure, but my feeling is you don't develop CD overnight either so it will take time.  And for the first time this therapy offers hope of cure instead of just shutting down the adaptive immune system and masking symptoms.  

Hope I answered your questions.


----------



## David

It does indeed answer my questions.

Please keep us updated as to how you're doing


----------



## cicconeca

Thanks David, will do.  Anybody else out there with any updates as they are progressing through the trial?


----------



## Wendsjoy

Hi All  cicconeca, glad that you found the trial and that you found us  Welcome!  I have a very similar story to you. 
Anyway, here is my update: I just got back from my week 16 visit in vancouver. I am doing pretty well. I am not in remission but i am better than I have been. I still have up and downs but my downs have not been so bad and my ups feel like remission sometimes, which is such a wonderful feeling. I really wish that I had been able to achieve sustained remission with this study quickly, but it is possible that the positive affect will continue to build and i could still get there. time will tell. for those of you who want all the details, my bm's are usually pretty formed, 1-2 per day with moderate urgency and mild pain, no blood, my fissure is still healing (the formed stool doesn't help that) i still have stomach pain sometimes and bloating with gas but those have improved slightly. i still feel fatigued and just generally yucky some days but not everyday anymore. still no joint pain.
last time i wrote i was battling a major head cold, that went away finally and now i am battling a lovely uti. i hate antibiotics but took them after a few days of terrible pain and they didn't even work! ugh hopefully that will resolve soon and its not something related to the crohns or make it worse!


----------



## Poppysocks

So as of now, I am not going to be participating in the trial. There's too much of a chance that I get the placebo and get extremely sick while off remicade.

Remicade is not fixing me, as evidenced by my latest colonoscopy, but it's keeping things from becoming unbearable, therefore I can't really take the chance. Sucks this thing is so far away from being approved for market use.

Oh well for now.

edit - plus side is I got a fecal cal test done for the first time ever and my level was 1240. Not so good lol. CRP is 15.


----------



## rollinstone

How's everyone else travelling? Been a bit quiet which hopefully is a good sign that you're doing better and getting on w life?


----------



## David

Wendsjoy,

That's awesome that you saw some significant improvement!  I wish you were able to stay on the treatment longer.  I hope things continue to improve going forward for you.  Sucks about the UTI though


----------



## David

Poppysocks, with a fecal calprotectin that high, your doctor needs to change SOMETHING up.  I don't know if duration between your Remicade dosages can be shortened as I don't know your time between dosages, but keeping your treatment regimen as is would be a big mistake in my opinion.


----------



## cicconeca

I'm curious about those who were previously in the compassionate use program, especially as to the timing of their recovery.  Did it take weeks or months and at what point was stable remission achieved.  I've heard Dr. Sutcliffe say it's possible it may take at least 4 months of therapy for a lasting clinical response.  I know Tyler, Natalia and Colleen have participated in this thread before.  Is there any chance you guys could go more in detail about your recovery timeline?


----------



## Poppysocks

David said:


> Poppysocks, with a fecal calprotectin that high, your doctor needs to change SOMETHING up.  I don't know if duration between your Remicade dosages can be shortened as I don't know your time between dosages, but keeping your treatment regimen as is would be a big mistake in my opinion.


I know it's high. Believe me, I'm looking for all other possibilities right now.

I have been thinking of adding Methotrexate to the mix, and going back to monthly remicade infusions. I also have an appointment with an immunologist next week to talk about ivig. Believe me, I'm not just sitting around. GI docs around Naples are all horrid. 

In addition to all that, this whole year I've been experimenting with diet, trying to spread out my remicade's as much as possible to see if it was helping. I've at least found out I'm very sensitive to dairy. I broke out in Shingles at the end of last year probably due to the Remi, and I've been trying to spread them out as much as possible. Prior to the Shingles the Remi wasn't keeping my inflammation markers down either, and I hadn't had a formed bowel movement in as long as I could remember. I added Mesalamine enemas to the mix and they've improved the formation of my BM's greatly. Hasn't fixed the sticture or inflammation though obviously.

Doc said he was going to set me up with a colorectoral surgeon but haven't heard from him. Not that it matters, I know what the surgeon is going to recommend, and I'm not doing it. Don't care.

Weird thing is, is I actually feel pretty good. Nothing is hurting as long as I stay away from certain foods (dairy). Doesn't hurt when I go to the bathroom. If I push out my Remi's past 7-8 weeks it starts to get painful and I really have to force myself to eat. My appetite has been very lacking the past few days, which is probably a sign of the inflammation. Other than that though I feel good. Of course I say this, I haven't been "truly" healthy in so long I don't even know what it feels like.

Sorry to hijack SSi Thread. Carry on. Wish they could put ssi on fast track status or something.


----------



## Trevor

Still here too 

Feeling pretty great still, same old ups and downs but still trending up. Been a stressful month or so with work but I survived and almost have caught up enough to focus a little more on recovery.

I'm really just holding my breath. Things right now are really good and if they keep getting better that's pretty amazing. Just can't help thinking it's too good to be true.

I know, I know, think positive. If only it were that easy, haha.

Still iffy joints. Fingers and toes mostly, wrists and ankles occasionally. Does seem very weather dependent but is mild and 100x improved from the last couple of years.

Odd stomach pains still, cramps, gurgling (less noise and less often but still there) and the occasional bit of gas or heartburn but other than the pain/cramping I probably rate lower than your average 20-something North American on that scale. 

My weight has been up and down like crazy since this time last year without a real rhyme or reason at times but it's starting to seem like it's normalizing as well and I am gaining or loosing weight in relation to thing like food and exercise again.


----------



## David

Trevor, did they by chance give you any of your lab results during all of this?


----------



## Trevor

Nope! But they did offer and I've been meaning to get it figured out shortly. I have to go in soon to renew my Mezavant so I'll see if I can get some info.

Fecal Cal and CRP - anything else of specific interest? Should have quite a lot of info banked from the last 9 months.


----------



## David

Anything you're willing to provide but those are the big two for sure.  I'm super curious.


----------



## cicconeca

David I will also give you my fecal calprotectin and CRP trends, for whatever it's worth!


----------



## PatientlyMary

My passport will be here in a week! I'll talk to the study nurse on Monday or Tuesday. I really hope they take me.


----------



## Poppysocks

How's everyone doing?


----------



## bees

Still feeling great!

I barely notice any symptoms these days when I stick to the diet that over the years I've learned helps me (reduced intake of dairy, red meat, sugar, and fat, increase in probiotic rich foods like kimchi). Did a 5 hour road trip this weekend and my knees got pretty sore from staying in the same position for too long.

I'm now done the study and my last labs. I have agreed to participate in the follow up study for this treatment (apparently I'm the first), which involves periodic phone interviews.

I live 5 minutes from the Qu folks, I'll have to pop over some time and get copies of my test results for you guys.


----------



## Poppysocks

bees said:


> Still feeling great!
> 
> I barely notice any symptoms these days when I stick to the diet that over the years I've learned helps me (reduced intake of dairy, red meat, sugar, and fat, increase in probiotic rich foods like kimchi). Did a 5 hour road trip this weekend and my knees got pretty sore from staying in the same position for too long.
> 
> I'm now done the study and my last labs. I have agreed to participate in the follow up study for this treatment (apparently I'm the first), which involves periodic phone interviews.
> 
> I live 5 minutes from the Qu folks, I'll have to pop over some time and get copies of my test results for you guys.


Bees, what was your fecal cal and crp before and after taking the treatment?


----------



## rollinstone

Any updates? Everyone has been really quiet which I hope is a good thing, trev, wendsjoy, very interested to see oh you guys are going, likewise sir clausin, how are you going?


----------



## PatientlyMary

My specimens when out Tuesday from Quest. Abby said it should take about a week for results, then I'll know if I'm going. Did anybody get their lab results that fast or did it take longer?


----------



## Wendsjoy

Hey everyone, sorry for the absence. I got a new job and have been super busy with the family lately. 
I am not doing all that great. I am not sure that I was on the SSI long enough. It really worked for me. I didn't realize how good i was actually feeling until I went off of it and have been without it for a while now. I wish they could get it approved fast so that I can get it again and stay on it longer this time! Good luck to all of you who are getting involved. It has a lot of promise for us Crohnies


----------



## rollinstone

That sucks you're not doing so well, hope you feel better soon, what are your plans for getting over the recent hump or to tied you ever until ssi is readily available? Hopefully it gets fast tracked once the trials show efficacy.


----------



## Wendsjoy

Not sure yet what the plans are...I have an appointment with my GI next week. Not sure what I want to do yet, been researching a lot and trying to decide which road I want to go down.  Just praying for fast approval somehow!
I am still so thankful that I was able to participate in this study, even if it was a short lived relief. It really did help me. I made a little graph of my lab work. It is pretty cool to see it on paper. It certianly proved that the SSI did help me. A lot!


----------



## rollinstone

Well I think if you saw benefit from it, the chances that your problems are caused by some sort of mycobacterium or other infection are pretty good, so you might be one of the people that responds really well to anti-map antibiotics (they penetrate macrophages, the ssi vaccine looks at getting your body to make new macrophages and get rid of the old ones where the theory is that's what's malfunctioning bla bla I'm not scientist but it makes sense to me) either way I hope you find your golden bullet soon, maybe the ssi is it and you just need to be on it longer so your body can completely reboot the immune system, plz keep us posted either way. Bless


----------



## David

Wendsjoy said:


> Hey everyone, sorry for the absence. I got a new job and have been super busy with the family lately.
> I am not doing all that great. I am not sure that I was on the SSI long enough. It really worked for me. I didn't realize how good i was actually feeling until I went off of it and have been without it for a while now. I wish they could get it approved fast so that I can get it again and stay on it longer this time! Good luck to all of you who are getting involved. It has a lot of promise for us Crohnies




I'm so sorry to hear you've fallen back on hard times.  That makes me sad.  While I absolutely understand the need for proper testing and regulation of medications, it's times like this I wish Qu Biologics would just register SSI as a pesticide so that they could inject a few rats, make sure they don't die, then unleash it on humans for them to use as they please.

I hope your GI has some good treatment options for you.


----------



## Poppysocks

Its so promising these new vaccines being developed. I just wish they could be on some type of fast track status. People with crohns are suffering so badly and this would be such a great medication with minimal side effects and deeper remissions. 

They still have to do a 3rd trial. This could take another 3 yrs to get approved


----------



## Wendsjoy

I actually think 3 years is generous. I think it'll be more like 5 in the US. Maybe sooner in Canada. Time will tell. It's still a great thing. Especially for the next generation of Chronies. The numbers are only growing. I have an 11 year old cousin just diagnosed and suffering  tremendously. Hopefully it'll be soon enough to save him from surgery. Or to save my own children if they end up with this because of their genetic makeup.


----------



## Reef08

Poppysocks said:


> Its so promising these new vaccines being developed. I just wish they could be on some type of fast track status. People with crohns are suffering so badly and this would be such a great medication with minimal side effects and deeper remissions.
> 
> They still have to do a 3rd trial. This could take another 3 yrs to get approved


There's no way it'll be done in 3 years. The current trial is only a phase 1/2a trial. Once this is done (and they're still recruiting patients), a phase 2b trial will have to start. After that a 3a, and then 3b trial will have to be done. We're looking at about another 8 years..maybe 5 if it's fast-tracked.


----------



## colleen.miller1428

I haven't posted in a while. For those who do not remember or didn't read back to my first post. I was one of the first people to have the complete SSI treatment experience and remission. 

I am so happy to see that this is making people feel better. Everyone with Crohns has different pains and experiences with the drugs that are available. We need to get at least another 60 people attempting to enroll in the trial in order to move this through. As posted previously, it could take 3+ years to get this to market. If we can be brave and encourage others to be brave, this amazing treatment could move through the system a lot faster. Which would mean it would be more readily available and generations to come would never have to live through this experience. 

Keep spreading the word and getting healthy! And a HUGE thanks to everyone trying this!


----------



## baistuff

A few comments. 

1) I have spoken to some folks high up in QU biologics and Univ of BC.  They really may be onto something- SSI is really something to pay attention to down the road.

2) "down the road" though cannot be overemphasized enough. Keep in mind the current tiral is really all about safety.  Yes, CDAI/HBI scores are being looked at, but scopes, biopsies are not being done. This is YEARS away from being available. Keep in mind each trial can take years to conduct, review, write up, get peer reviewed, published, confirmed. I think 3-5 years is a pipe dream- 8, maybe if everything goes on time. Possbily longer.  Now, if there are some staggering incredible results or another compassionate use occurs with great results, some fastracking is possible, but beyond that this is years, MANY years from being away.

3) The QBECO SSI vaccine contains an inactivated E. coli bug. E. Coli is NOT at all anywhere near the same type of organism as MAP. Sure, it would confirm bacteria/infection is involved with crohns, but we basically know that already. 

4) What is hurting QU biologics right now is location. It is not easy for patients to get out to Vancouver for 10 day stretches, even with costs taken care of.  Not many people can drop family/jobs for these stretches and commit to going all the way out there.  I wish they would join forces with a US Northeast university or company and have open an arm here. I honestly think if there were an arm here in NY of Philly this would take off and get a lot more publicity, and maybe speed the studies up a little. 

In a nutshell, this is very promising research. They have theory, data, and scholarly approach.  But the wheels turn VERY VERY slowly. Not something any of us want to hear, but it is the reality.


----------



## RandomSuccess

***


----------



## whyclef

Spoke with rep from Qu Biologics today, in process of getting medical records for the SSI Trial.  If I am approved and all goes according to plan she said I would likely come for first visit and first injection near the end of November.  How long did it take those accepted to go from step one to first injection? 

This trial is something I'm willing to attempt before moving onto Azathioprine as my IBD doctor would prefer.  Currently on 20mg Prednisone as dropping to anything lower causes me to flare right now.


----------



## rollinstone

whyclef said:


> Spoke with rep from Qu Biologics today, in process of getting medical records for the SSI Trial.  If I am approved and all goes according to plan she said I would likely come for first visit and first injection near the end of November.  How long did it take those accepted to go from step one to first injection?
> 
> This trial is something I'm willing to attempt before moving onto Azathioprine as my IBD doctor would prefer.  Currently on 20mg Prednisone as dropping to anything lower causes me to flare right now.


Definitely try get in the trial over aza, could fix you up for good.

 As for ssi taking years, what about compassionate use? For instance inAustralia if people are all out of options they are allowed to use medication still under trial through compassionate use, surely SSI would be the same, albeit in Canada...


----------



## PatientlyMary

whyclef said:


> Spoke with rep from Qu Biologics today, in process of getting medical records for the SSI Trial.  If I am approved and all goes according to plan she said I would likely come for first visit and first injection near the end of November.  How long did it take those accepted to go from step one to first injection?


If you have your passport and medical documentation of Crohn's diagnosis that is at least six months old, you can print out the pages to sign with the study nurse then she will send out your specimen kit right away.


----------



## whyclef

PatientlyMary said:


> If you have your passport and medical documentation of Crohn's diagnosis that is at least six months old, you can print out the pages to sign with the study nurse then she will send out your specimen kit right away.


I heard from Abby (Qu Trial Admin Assistant) on Friday saying that she was mailing my specimen kit, so I should receive it some time this next week.  All of the people at Qu have been great to work with through the process.

Also, impressed with my IBD physician as he took time to research the Qu trial and personally call Dr. Bressler plus one other lead IBD researcher in the USA to ask questions.  He called me to explain all he had learned and said he felt like it was good for me to give this trial a Go over Azathioprine.  I think what really peaked his curiosity was when I shared the results that some of my fellow Crohnies experienced from the SSI Vaccine Trial.


----------



## David

Sounds like one heck of a doctor you have there whyclef.  What was his take on everything?


----------



## Lady Organic

I think its too bad QuBiogics demands CRP level as a main mesuring criteria. This discriminate a lot of potential patients who mostly only have endoscopic findings as proof of disease activity and possibly a different disease phenotypes. many of us do not show increase CRP level until reaching an extreme point of disease activity. I am in a moderate recto-colitis flare right now and my CRP is not showing, only my plaquets are a bit elevated, so I cant partcipate in this study unfortunately. 

I tried to enroll in a FMT trial in Alberta too, got my GI approuval, but the researcher only wants Alberta people, yet she wants mild to moderate and now my colitis has escalated into a more severe category unfortunately so i coundnt participate anyway. after coloscopy my GI prescribed 40mg pred, but I feel I'll have to increase it to 50 tomorrow because my symptoms are not improuving much to my expectations since 3 days, as they did very rapdly, within days, almost back to normal, in the past. Lots of unknown coming ahead for me...


----------



## nogutsnoglory

I agree that I wish they had a local trial here in the states. It's so great this is being done but the location is a big issue.


----------



## rollinstone

My crp is never really elevated either


----------



## PatientlyMary

Lady Organic said:


> I think its too bad QuBiogics demands CRP level as a main mesuring criteria. This discriminate a lot of potential patients who mostly only have endoscopic findings as proof of disease activity and possibly a different disease phenotypes. many of us do not show increase CRP level until reaching an extreme point of disease activity. I am in a moderate recto-colitis flare right now and my CRP is not showing, only my plaquets are a bit elevated, so I cant partcipate in this study unfortunately.


I think you should still try to get in, CRP is not the only way to show active disease for the Qu trial. If you haven't already called them, it wouldn't hurt to ask more about it.

I don't know as much about testing and labs, but the Qu  e-mail said something about endoscopy results? See below:


......A copy of the endoscopy OR radiology report(s) used to confirm your diagnosis of Crohn’s Disease 
......A copy of the histopathology report(s) used to confirm your diagnosis of Crohn’s Disease 
.......A copy of any lab investigations, endoscopy, radiology and relevant medical history from within the last 3 months


----------



## PatientlyMary

rollinstone said:


> My crp is never really elevated either


I just want to add that my CPR is never elevated either, and I stoned poor Abby about this from the start, because I was sure that I would never be accepted into the trail. But, she said that they have different (lower, I guess?) numbers that they are looking for. Sure enough, my serum results came back positive for the trial. 

And you can always do the screening package again if you are not positive the first time.


----------



## whyclef

David said:


> Sounds like one heck of a doctor you have there whyclef.  What was his take on everything?


My IBD doctor said that he was hoping for more study on how the treatment actually works, such as lab rat studies and research papers to show the mechanism of action.  However, he said that he felt confident the trial was safe based on his conversations with Dr. Bressler and based on the self-reported results I shared with him from this forum.  Considering the chance it could put me into remission for a year or longer, he felt it was certainly worth putting the immunomodulators on hold and trying to get approved for the Qu Trial. I would be his first patient in this trial, so I perceived he is also intrigued to see how I do since it could be helpful to other IBD patients at his practice.


----------



## Lady Organic

thanks Mary,

I had called in the summer when I was wrongly diagnosed by my GP with an perianal abscess (turned out to be hemmorhoid). My GI was on vacation, so I took antibiotics while waiting for his return... I am thinking maybe those antibiotics could have even possibly played a role in my current flare. 

I spoke with the rep who mentionned a specific number for CRP which i knew I would only get if my disease would be really extreme. But I 'll definately give them a call again tomorrow, mentionning my new story. thx.


----------



## baistuff

Keep in mind this is an early study that is not involving pre and post study scopes/biopsiees, but still requires some objective criteria as an outcome measure. Since there is a placebo control there has to be some level of objective control on results as well. Simply doing a CDAI or HBI score can skew results simply because of placebo effect.  Also, please remember that the poster presented at DDW this past May in Chicago was about folks with "moderate to severe" disease.  The fact remains that most people with moderate to severe disease chronically will often develop some abnormalities in labs. True, not everyone will, but the CRP is NOT the only marker they are using. 

My bigger complaint is about location.  Though there may be financial (and other) reasons behind it, I wish they would partner and open another arm to this study.   I do not have the time or desire to leave my family and job for 10 days at a time to go more than 3K miles, and I imagine many other don't either, even if it is all expenses paid.


----------



## xeridea

It was announced yesterday that the Qu SSI Crohn's trial completed (passed) it's Independent Safety Review. This is a somewhat important milestone and means that the treatment has been deemed safe on humans and that the trial can continue.

Here's one source on the story: http://www.marketwired.com/press-re...mpletes-independent-safety-review-1962252.htm


----------



## PatientlyMary

I just got off the phone with Abby at Qu and it looks like I'll be there November 10-14. And I can fly home Friday afternoon!

I will only be in Vancouver for FIVE days!!!

If you are travelling a long distance to Vancouver, they only require five days (M-F) now for week one & week eight of the trial.

I hope more people will be able to try to get in this Qu trial now. Every little bit helps.


----------



## rollinstone

Paging some of the people in the trial, Trevor, bees etc, how are you guys going? Been awful quiet from you all, hope that's a good sign.


----------



## dave13

I talked to Abby yesterday.I told her a big concern for me is if it does not work for me,can I go back to Remicade? The timing is good because I just had my infusion and my next is not for another eight weeks.Abby said you have to be off biologics for at least two months to be considered,so I can talk with my GI before the next infusion.

I have a good rapport with his nurse.I'll call her and see if she can get my GI to check out the QU website.I would like to go into my appointment with him already knowing what I would like to do.Instead of the appointment being the first time he hears of it.

I have talked to my colorectal surgeon and he feels I should not do it.He would be for it if it wasn't double blind.I know his concern is genuine.What damage would CD do to me if I got a placebo and it didn't work? If I was told I could go back to Remicade(it is helping me)if the trial didn't work I would call Abby right back and say sign me up.

What if it did work? I'll call my GI's office.


----------



## Trevor

rollinstone said:


> Paging some of the people in the trial, Trevor, bees etc, how are you guys going? Been awful quiet from you all, hope that's a good sign.


Oh boy. Not good news...

Crashed and burned about 8 weeks after the end of the trial. Actually pretty spectacularly. No more job, back on Pred and just waiting for the Humira 

Sorry, guys.

If you're reading this and about to start or considering starting the SSI, it did some good stuff for me. It sucks it couldn't keep me where I was once I stopped taking it but this is where I was before so it's not that it made me worse.

I'll try and be around more. Been a rough go the last few weeks.


----------



## David

Damn, that makes me so sad Trevor.  I'm so sorry 

*hugs*

You flared which caused you to lose your job?  Or the other way around?


----------



## Trevor

David said:


> Damn, that makes me so sad Trevor.  I'm so sorry
> 
> *hugs*
> 
> You flared which caused you to lose your job?  Or the other way around?


Hard to say, haha. If I were healthy I'd for sure have the job still but there were quite a few factors. My manager left just as I was getting bad again and the extra stress for sure did not help. My whole life kinda blew up so the job seems less important right now. Thank god for family and friends.

The Pred + pot is not a great mix (for me) so I'm just on Pred (tapered quickly from 50 to 35 after it kicked in and seem to be doing well enough) and the Humira should be showing up any day now!


----------



## PatientlyMary

That's awful Trevor (and Wendsjoy). It was good to hear good news for once (while it lasted). I'm actually starting the trial Dec 15, once my labs come back again. The time ran out on my first try. I'm going to ask them if they will keep some of us on the drug longer if it's necessary for remission, like in the compassionate use trial?


----------



## xeridea

Trevor said:


> Oh boy. Not good news...
> 
> Crashed and burned about 8 weeks after the end of the trial. Actually pretty spectacularly. No more job, back on Pred and just waiting for the Humira


Trevor, sorry to hear you became unwell soon after stopping treatment. Hope that you can get your symptoms back under control soon. 

Thank you for participating in the trial and keeping us updated.


----------



## Wendsjoy

Trevor!! Good to hear from you! We are in the same boat once again.  hope things look up for you really soon!!


----------



## rollinstone

Oh man, guttered for you  hope you start feeling better soon


----------



## rollinstone

Anyone have any idea of how long the compassionate use program was for as opposed to this 8 week trial?


----------



## xeridea

rollinstone said:


> Anyone have any idea of how long the compassionate use program was for as opposed to this 8 week trial?


From the Qu site, perhaps at least 3 months.

http://www.qubiologics.com/studies/compassionate-human-use-program/

Ten of ten patients had a therapeutic response to treatment, based on patient-reported improvement in symptoms. The majority of patients achieved therapeutic response within one to three weeks of starting treatment. Seven of the ten patients (70%) with Crohn’s disease had full resolution of clinical symptoms after completing a course of QBECO treatment of three months duration or more. Three of these patients have had sustained clinical remission after discontinuing all medications including SSI treatment. The longest clinical remission is ongoing, after 4 years. Three of ten patients (30%) have had follow-up colonoscopies or CT scan with confirmation of full remission.


----------



## Wendsjoy

I think Tyler Wilson was on it for over a year, not exactly sure tho. That's what phase 2 will probably be. Dose and duration.


----------



## rollinstone

Oh man, I really hope they can get compassionate grounds to speed up approval.. 8 weeks does seem pretty short, hank all of you so much for partaking in the study


----------



## Trevor

Started Humira last night along with olestyr. Fingers crossed.

And yet another journey begins. These things always happen right before Christmas...


----------



## Trevor

Wendsjoy said:


> I think Tyler Wilson was on it for over a year, not exactly sure tho. That's what phase 2 will probably be. Dose and duration.


Very interested to see where it goes from here.


----------



## PatientlyMary

I'm wondering how much different the results are for those who are 'responders' and are technically on SSI for the whole 16 weeks of the trial vs nonresponders, who are on the drug the last 8 weeks only?


----------



## Trevor

Update: added Ativan and some sort of anxiety/depression med - Pred really messed with my nerves/head. Hopefully short term as they get me all the way off the steriods.

Combo of humira, Mezavant and Olyster (sp?) seems to be kicking in. What a mess, lol.

Going to give the trial a call as soon as I get my head straight and see if they have anything to say as far as future opportunities.


----------



## rollinstone

You'll get there bro, anxiety can be brutal, I was going through it for a little while, I think it's intrinsically linked to intestinal inflamation.. Hopefully ssi will be able to offer compassionate use of the drug, I don't understand why they can't I mean there are some scary drugs that are allowed to be used off label in certain circumstances


----------



## Poppysocks

rollinstone said:


> You'll get there bro, anxiety can be brutal, I was going through it for a little while, I think it's intrinsically linked to intestinal inflamation.. Hopefully ssi will be able to offer compassionate use of the drug, I don't understand why they can't I mean there are some scary drugs that are allowed to be used off label in certain circumstances


What does it mean if a drug is offered as "compassionate use"?


----------



## rollinstone

Well i think, and I could be wrong but afaik it's when something is given to patients with the drug being approved for that condition, now that being said the drug may be approved for another condition.. For instance there are some people here in Aus using stelara on compassionate use because they failed the other biologics.. I'm sure once this trial is done they'll be able to offer it in some circumstances, let's hope anyway.


----------



## David

How are you feeling Trevor?  Has the Humira kicked in for you I hope?


----------



## whyclef

Accepted to trial and travel booked.  I will be there January 5-9, 2015.  Will keep everyone posted on how it goes.  Right now sitting at 20mg prednisone as you cannot change steroid dosage for 2 weeks prior to trial.


----------



## David

Awesome whyclef, I hope everything works out well for you.  But please let us know either way.  Thank you for taking part.


----------



## PatientlyMary

I got home from Vancouver a week and a half ago, but my 77 year old mom had a medical emergency in NY the day I was supposed to start the trial, on Dec 15th.

I didn't actually qualify for the trial. My pre-trial diary didn't show my normal disease activity for various reasons, stress over flying conditions and family stuff. I told Shelly that the diary wasn't representational of my normal life so we agreed to resubmit when I didn't have worries about weather, etc. By the time I got back to the hotel on Monday afternoon, I had messages saying mom's had stroke, which we later discovered was actually a brain tumor. At that point that I was so grateful not to be in the trial. I would not be able to return in eight weeks if her prognosis is bad. We have been waiting for her biopsy results.


----------



## xeridea

*SSI Vaccine Q&A with Dr. Gunn*

Dr. Gunn from Qu Biologics recently did a Reddit Q&A session (AMA). Here's the thread with Dr. Gunn's answers. 

My question sought a clarification of whether this is AIEC-specific or not. I'm very pleased to learn that it tries to fix the innate immune system's macrophage dysfunction, so it can target any pathogenic trigger. 

Give it a read. Exciting stuff!


----------



## xeridea

Just wanted to bump this on the forum to direct people to recent Q&A with Dr. Hal Gunn over on this Reddit AMA.


----------



## David

Thanks xeridea, I appreciate it.


----------



## Crohn2357

xeridea said:


> Just wanted to bump this on the forum to direct people to recent Q&A with Dr. Hal Gunn over on this Reddit AMA.


Thanks. Copied into another ibd forum


----------



## xeridea

This treatment just granted U.S. patent. 

http://www.qubiologics.com/qu-biolo...nt-for-use-of-e-coli-to-treat-crohns-disease/


----------



## David

Very cool, good for them.  Thanks for posting about the patent!


----------



## k_dubs25

I just submitted the pre-screening questionnaire for the study and was wondering if anyone knows what medications (or what medications within a certain time period) make you ineligible. I'm currently on Entyvio and methotrexate, but I'm scheduled to switch to Remicade in a couple of weeks. I don't want to get my hopes up if there are restrictions. Thanks!


----------



## David

My understanding is being on Remicade will disqualify you.  I'm not sure about Entyvio.


----------



## Wendsjoy

Any immune modulating meds may DQ you. The SSI is an immuno-modulator so you probably can't be immunosuppressed. 
Not sure though. Hopefully it works out for you!


----------



## David

Hey Wendsjoy, good to see you.  How ya been feeling?


----------



## Wendsjoy

Hi! I'm ok. Started humira about a month ago :/ not happy about that but hoping it helps and I can stop taking it when/if the SSI becomes available in the U.S.!


----------



## David

I hope the Humira gets you in remission soon Wendsjoy!

*hugs*


----------



## k_dubs25

In case this helps anyone else, Entyvio does DQ you like the other biologics. Abby from the trial said that they probably just haven't updated the website yet.


----------



## Lady Organic

Ive just received this email from Qu Biologics:

We are pleased to share with you the published data of our compassionate use program involving 10 patients with moderate-to-severe Crohn's disease. The data has been published in Gastroenterology Research and Practice, Volume 2015 (2015), Article ID 231243, 7 pages

http://www.hindawi.com/journals/grp..._campaign=CUP+Data+Published&utm_medium=email

I've also seen in the website that a reputable IBD gastroenterologist from Calgary has recently joined the team.


----------



## KHCD5

Anyone currently participating in the trial? I'm very curious about this drug and if it has achieved prolonged remission for anyone besides the compassionate use study.  Also after going through the study would you recommend it to others?


----------



## chosen

_*If anyone is interested in tuning in to this in 15 minutes:*_

Qu IBD Community Advisory Panel
Meeting Agenda
June 23, 2015
5:30pm -7:00pm PDT (8:30pm - 10:00pm EDT)

Call in details
Toll free call-in number: 1.855.423.3955 (Canada/US)  
Participant code: 6273948

If you require a toll free number outside of Canada/US or have any difficulties accessing the call, please contact Ms. Gigi Cheung at info@qubiologics.com. 

Add this meeting to your calendar!
Download for Google calendar
Download iCal appointment

Background
In 2007, Qu Biologics was launched with a vision to develop treatments that restore health in a way compatible with our body's own healing capacities. This very different approach and vision is reflected in the innovation, passion and excitement that inspire us in our work.  We are developing Site Specific Immunomodulators (SSIs).  Rather than blocking or stimulating a single receptor or pathway, SSIs are designed to restore the body's normal immune response.  SSIs, derived from components of killed bacteria, aim to stimulate an innate immune response in targeted organs or tissues to potentially reverse the chronic inflammation underlying many conditions including cancer and immune-related diseases, such as inflammatory bowel disease. 

We are currently recruiting 60 participants for a clinical trial in Crohn's disease and expect to start a clinical trial in ulcerative colitis in a few weeks.

Previous to these clinical trials, ten patients with Crohn's disease and two patients with ulcerative colitis were treated with Qu Biologics' SSIs in a compassionate use program. Response associated with SSI treatment was as follows:

Crohn's disease
All 10 patients had a therapeutic response to SSI treatment, with improvement in symptoms
7 of 10 patients had full resolution of clinical symptoms with a course of SSI treatment of three months or more
3 patients are in sustained ongoing clinical remission after discontinuing all medication, including SSI treatment.
All 3 patients in sustained clinical remission have had a follow-up colonoscopy with confirmation of full remission.
The longest clinical remission is 4.5 years ongoing.
Ulcerative colitis
Both patients went into sustained clinical remission during SSI treatment
Both patients were able to discontinue all medications including SSI treatment
One patient remains in ongoing sustained clinical remission (2+ years), while the second patient was in remission for 17 months before having a recurrence.

Qu's IBD Community Advisory Panel was formed to help in our understanding of patient perspectives as it relates to IBD treatment and clinical trial design. 

Thank you very much for joining Qu's IBD Community Advisory Panel.  We sincerely appreciate your time and hope that the valuable insight we receive from you will help to make us a better patient-focused company and that we can ultimately develop and deliver relevant treatments to improve the lives of those living with IBD.

Topic: IBD Treatment Options

Today's topic will be about IBD treatment options. We are currently recruiting participants for a clinical trial in Crohn's disease and plan to begin a clinical trial in ulcerative colitis in a few weeks. Both trials involve the use of Qu's investigational treatment, QBECO SSI, which is derived from components of inactivated E. coli, and designed to stimulate an innate immune response in the GI tract and restore normal immune function. For additional information, visit www.qucrohnstrial.com.  The goal of this meeting is to help us to understand the following:
What kind of new IBD treatments are exciting to you?
In your opinion, how does QBECO SSI treatment compare with other approved and experimental treatments?
What is your experience with other IBD treatments?


----------



## Lady Organic

I was thinking this afternoon that the fact that Dr Panaccione joined the team is an extremly good thing. THis may  most likely mean that with the primarily results as of december 2014, the trial was going well. He would have certainly not joined the team if the primarily results were dissapointing... Dr Panaccione is a IBD specialist in Calgary with an interesting resume, he is professor and director of the IBD clinic and gastroenterology research. Also won an award from Crohns and colitis Canada. I think this is a super great addition which will help this new vaccine reach higher levels and not be forgotten or taken lightly. 
http://www.qucrohnstrial.com/status...ologist-dr-remo-panaccione-ibd-advisory-team/


----------



## Lady Organic

they have also opened new trial site locations, Calgary (dr Pannacione) and Toronto along as the UC clinical trial. sounds really promising!!!

on a second note, I have contacted the team and the treatment is exactly the same for both CD and UC.


----------



## Sue-2009

Have we approved it? And if you are on humira or been on remicade. Does that disqualify you?


----------



## Wendy M

I started the trial for UC this past Tuesday in Vancouver.  I believe I am patient #1 for the UC trial. It is a bit different than the crohns trial.  It is a 40 week trial, open label so we all will be on the drug from the start.  There are 3 different doses, chosen randomly, for the first 8 weeks. After that they will decide, from your reaction to the drug, if there needs to be any adjustment before you continue for the remainder of the time.  It is a very small trial, 15 people in all: 5 in Vancouver, 5 in Calgary and 5 in  Toronto .  I was on a wait list for about 2 years. Heard from Dr Gunn in early April and started the screening process in mid August with my first injection on September 15.  It was quite stressful waiting to find out if I would be eligible or not.  Now its just a waiting game to see if it works.


----------



## chosen

Wendy M said:


> I started the trial for UC this past Tuesday in Vancouver.  I believe I am patient #1 for the UC trial. It is a bit different than the crohns trial.  It is a 40 week trial, open label so we all will be on the drug from the start.  There are 3 different doses, chosen randomly, for the first 8 weeks. After that they will decide, from your reaction to the drug, if there needs to be any adjustment before you continue for the remainder of the time.  It is a very small trial, 15 people in all: 5 in Vancouver, 5 in Calgary and 5 in  Toronto .  I was on a wait list for about 2 years. Heard from Dr Gunn in early April and started the screening process in mid August with my first injection on September 15.  It was quite stressful waiting to find out if I would be eligible or not.  Now its just a waiting game to see if it works.


Wendy, best of luck to you! Please keep us updated!


----------



## David

Best of luck Wendy.  Please keep us updated!


----------



## Lady Organic

yeah really exciting Wendy! I cant wait to see the outcome. may I ask how active is your colitis right now?


----------



## Wendy M

I have had UC for 25 years and never been in full remission.  I have had better times and worse times.  I was actually doing the best I had ever done about 1 year ago. I was seeing a " good" naturopath for 5 years and started taking LDN 2 years ago.  At that point I started adding some more food, as I had been on a very limited diet of about 25 items.   Then I put my neck out and had to get a couple of shots of muscle relaxant and an anti inflamatory as well as taking Robaxacet.  I also decided to add MM in capsule and oil form.  Whether because of one or a combination I went into a flair.  I discontinued the MM.  And my neck problems were better so didn't need to take any more medication.  However my flair continued.  I was continuing with the  naturopath and LDN, however I still wasn't doing great.  I did slowly start to do better.  But the problem with waiting for the SSI trial is it was a balancing act, not wanting to stay in a flair but not wanting to be well enough to not be eligible to be in the trial. Fortunately I made it into the trial by just being sick enough.  So long story short I have moderate disease at this time.


----------



## David

Thanks for the additional information Wendy.  We're all certainly rooting for you and appreciate your willingness and strength to take part in this trial for the benefit of all!


----------



## Wendy M

Just thought I would post an update for everyone. Today will be my 5th injection. Some interesting symptoms/results.  After the first injection, by the nurse, I didn't feel any different until the 3rd day.  I woke up with nausea that was quite bad. It was all I could do to drive an hour to the GI center to give myself the 2nd injection.  The nausea was gone by late afternoon.  With regards to BM,s I had a couple of better days and a couple of worse days. However yesterday, 1 week from my first injection, I had a "normal person" day. One normal BM in the morning and that was it for the rest of the day.  As well I felt good.  I doubt that it would just be perfect like that from now on but certainly a good sign!  I am trying not to be too optimistic as the emotional let down if and when things aren't good is pretty devastating.


----------



## David

Thanks for the update Wendy.  I hope you start getting lots of normal person days


----------



## Lady Organic

sounds promising! are you still taking the LND along with the SSI? or SSI is your only UC treatment?


----------



## Wendy M

I am still taking everything I was taking prior to the trial. So yes LDN as well as salofalk tablets( which I have taken for years even though I don't really think they do much). I also take a lot of supplements from my naturopath and a probiotic.  I guess the hope is to be well enough to discontinue some of the drugs/supplements.  But I would certainly be nervous to change anything if I was doing well. Wouldn't want to rock the boat.


----------



## Om3ga1

Now if we can get this in the good ol' USA.


----------



## Wendy M

I have completed my second week with the SSI treatment. Some interesting things:
Woke up Saturday morning at 3am with a bad headache and nausea.  Actually threw up around 4.  Went back to sleep and felt a little better by 8.  Nausea was gone by late afternoon.  
Then yesterday noticed I was getting a cold sore.  I haven't had one since I was a kid.  
I looked up cold sores and one of the causes listed was a change in the immune system. So I am taking all of this as a good sign, that things are going on with my immune system. 
I am also feeling more tired than usual. 
As for bm's things are a little better:
- a little less stomach pain or ache
- a little less urgency
- a little better form
My hope is that I will just continue to improve until I'm in remission.  Fingers crossed!


----------



## David

Thanks for the update Wendy!  Be sure to let Qu Biologics know about the cold sore.


----------



## Wendy M

A weekly update for those of you that are following the SSI treatment. 
This week I haven't had any major nausea or pain.   I have felt a little achy, sort of like when you have the flu but a bit different.  So I don't think I'm getting a flu.  As for BMs they are slowly still improving.  Haven't had a 1, normal person day again, but definitely getting closer.  Although, as I am sure you can all understand, going out and about on a good day is sometimes as frightening as a bad day.  But still I'll  take good over bad every time.  As much as I would like to say that I'm in remission already I think after 25 years of this awful disease it will take time to get there.  I'm hopeful with the signs so far.  
David I will definitely let them know about the cold sore ...
They have given me a diary to keep track in and will be calling me next week for my info.


----------



## Seuxin

Hello guys,

Do you thinks this SSI Vaccine will be a good treatment for Crohn ? Any bad side effects ?

Thanks


----------



## David

Seuxin, I don't think there will be major side effects.  As to whether it will be a viable treatment, we'll see.  Our fingers are crossed!


----------



## Seuxin

Thanks  I hope this treatment will be better than Velozidumab and other anti tnf alpha.

Have you an idea when the trial results will be available ?

Thanks: )


----------



## David

Not for at least a couple of years from my understanding


----------



## Lady Organic

Not sure about the results, but I have been told by the rep that if the results are positive, we can think the treatment would be on the market in 4 to 5 years.


----------



## Seuxin

Hello,

4 to 5 years is a lot !
FDA could really speed up....

I hope the Crohn MAP vaccin could help us....or cure us....


----------



## Wendy M

Some disheartening news.  Since my last update I have gone backwards and am about where I started from with my symptoms.  They only two things I can come up with are: I did eat a little different over Thanksgiving.  I have followed an extremely rigid diet for years, so when I say I added a couple things it is nothing crazy or that I haven't had before - honey in my tea a little rice and potato.  I am basically on a Paleo diet.  The other thing, I changed the time I take my shot from afternoon to bedtime.  I have switched back to afternoon but only 1 shot so far.  I was reading back over the forum and it is interesting that the compassionate people had such wonderful results, full remission ranging from a week to a month. None of the trial people seem to have the same results. I am feeling very discouraged and would be interested in any thoughts on if you think the SSI can still work for me.


----------



## David

I'm so sorry Wendy   Hopefully this is a momentary relapse and things turn for the better again.


----------



## rollinstone

Wendy M said:


> Some disheartening news.  Since my last update I have gone backwards and am about where I started from with my symptoms.  They only two things I can come up with are: I did eat a little different over Thanksgiving.  I have followed an extremely rigid diet for years, so when I say I added a couple things it is nothing crazy or that I haven't had before - honey in my tea a little rice and potato.  I am basically on a Paleo diet.  The other thing, I changed the time I take my shot from afternoon to bedtime.  I have switched back to afternoon but only 1 shot so far.  I was reading back over the forum and it is interesting that the compassionate people had such wonderful results, full remission ranging from a week to a month. None of the trial people seem to have the same results. I am feeling very discouraged and would be interested in any thoughts on if you think the SSI can still work for me.


Hang in there Wendy, it's probably your stomach getting used to new foods, also the compassionate use people were on the SSI vaccine for a lot longer than the length of the current crohns trial, they all took it for varied lengths of time, which makes me think that some took longer to get to full remission than others. Are you in the UC trial or the crohns trial? I think the UC trial is longer. Anyway, we're rooting for you! Maybe you could ask the nurse next time if you're allowed to take anything that may help the SSI vaccine work, like oregano oil or a natural antibacterial. Also keep in mind that if you're in the crohns trial, you may be on the placebo for the first couple of weeks before they give you the good stuff.


----------



## Wendy M

Thanks for the support I appreciate it very much. I am in the UC trial, so no placebo. It was suppose to be for 40 weeks however my study nurse just told me that Qu has applied to Health Canada to amend the protocol. I am hoping it isn't approved as some of us may be taken off after 16 weeks if they deem us as non responders. And for those able to continue they would change the dose randomly.  She said she has never heard of any protocol changes once a trial has started.  Doesn't really sound right, as you decide if you want to be in the trial with the protocol that they give you.  
Hopefully I will start to feel better again soon.  There is a bit of a stomach bug going around here so maybe I caught that.


----------



## rollinstone

Wow, hopefully you get the full 40 weeks, I have to admit, whenever I have an upset stomach I go into panic mode and think it's a flare up, but sure enough it's usually just a stomach bug, so if there's one going around its most likely that, plus you said you changed your diet up. How far into it are you? I have a lot of faith in the vaccine, hopefully you start feeling better in the next day or two. Please keep us informed if you can! We're all rooting for you to get 100% better! God bless


----------



## CMac

Hi there, I have been on the UC trial for a week now! I started off with stomach pain, nausea, headache and fatigue for the first 5 days, today the pain is gone and seem to be adapting to the drug (hopefully). My nurse also told me how they might change the protocol, which was not nice to hear. I will also post weekly on my symptoms to give more info about the trial and answer any questions!
Cheers


----------



## Lady Organic

Hi CMac and welcome! Im glad you can keep us updated! Wishing you the best on this trial!


----------



## David

Thanks for joining cmac!  Best of luck in the trial and please keep us updated!


----------



## Wendy M

Hi CMac
I wondered if you could let us know your UC history and how you got into the trial.  Thanks.


----------



## CMac

Diagnosed 2 years ago with mild-moderate UC. Now it is Moderate-severe
- 10-15 bm a day with blood, mucus and severe urgency
- I have tried prednisone, Asacol, sulfasalozine, salofalk etc. Nothing worked. Never tried the biologics.
- I got into the trial just my researching online, And I meet the requirements for the trial, so I figured I would give it a shot. 

Feel free to ask anymore questions
Cheers


----------



## David

CMac, were you diagnosed by colonoscopy?


----------



## David

I just had a conversation with an employee of Qu Biologics:

1.  Wendy, they said it wasn't uncommon during the compassionate use trial for UC patients to have fluctuating symptoms out to eight or so weeks.  A 2 steps forward, 2 back, 2 forward, 1 back type of thing.  So fingers are definitely still crossed for you to see plenty of steps forward 

2.  The protocol change isn't a big deal from the perspective of:
A.  You don't have to change if you don't want to.
B.  The change is simply treatment out to 52 weeks instead of 40 weeks.  So if you respond well, you're probably going to want to do the change.  If you don't respond at all, then you might not change.

Hope that helps


----------



## CMac

David said:


> CMac, were you diagnosed by colonoscopy?


Yes, I was diagnosed by colonoscopy. I had a flexsig right before my trial started and it showed that the inflammation had become worse. (Moderate-severe)


----------



## Lady Organic

@CMac: are you taking any other medication aside from SSI?


----------



## CMac

I went off all medication about a month before going on the trial. I am not on any other meds, ssi only.


----------



## Lady Organic

I am curious to know when will be the next time you have monitoring and what kind of monitoring (blood works, fecal calprotectine or colonoscopy?) with the SSI team?


----------



## CMac

November 9th I go to the local life labs and get a blood test. And for all the other fun stuff it is at the 8 week mark from what I understand


----------



## Wendy M

Thanks David that definitely helps.  I just passed the 5 week mark so still time left for steps forward.  I have been feeling better the last couple of days so maybe it was a bit of a stomach bug.  Interesting about the protocol changes, what you got from Qu Biologics is different than what I was told from my study nurse.  I tend to think Qu would be more accurate. I hope so because that sounds better.  I am booked for my 8 week appointment on November 10 so hopefully will get updated info then.


----------



## David

I assure you the info I got is more accurate than what the study nurse provided.

Fingers crossed for you that it was a stomach bug or one of those short steps back!

*hugs*


----------



## David

How are you feeling Wendy?


----------



## Wendy M

Sorry I haven't posted an update.  Feeling pretty good.  Still doing the two steps forward, two back, two forward and one back scenario. So slow but moving in the right direction.  The biggest change I would say is that the form is better. Not all the time but more and more often. Definitely less pain and nausea.  Frequency is still about the same 2-4 times a day.  That is the one I would like to see more improvement.  However, we went to our cabin the last 2 weekends, which is a four hour drive.  As you all know traveling causes a lot of stress so I think that slowed down the rate of improvement. I am home for the next 4 weeks so only the regular life stresses. Tuesday is week 7 so hopefully just continue to get better.  As much as I would like to be in remission today, as long as there is continued improvement it keeps  hope alive.


----------



## David

Thanks for the update Wendy!  I hope you have a big step forward soon


----------



## Wendy M

So today is officially week 8.  I went for my appointment with the nurse and had my sigmoidoscopy.  Good news the sig showed no sign of UC.  The nurse told me that my scope looked like a normal persons, if they showed it to anyone they would not know that I had UC.  Unfortunetely my symptoms are not quite caught up to that.  They are still about the same: formed a lot of the time, still occasional diarrhea, with a total of 1-4 times per day.  
Apparently the changes to the trial have been approved by Health Canada and are now before the ethics Committee.  My nurse thinks it won't be a problem to have it approved. 
David I will have to call Qu because she let me know about quite q few changes that would effect me.  However I am on the drug for at least another 8 weeks.     
Some good news for anyone with UC they have upped the number of participants to 40.  The nurse is now screening #6 so if you are interested nows the time to give it a try.


----------



## Lady Organic

great news, I am so glad to read that! so at week 0 you had disease activity in your recto-sigmoid right? did they do a recto-sigmoidoscopy at week 0?

It already happened to me to be very early in a flare with 2 to 4  abnormal BMs/day and a fine endoscopic view. my GI declared ongoing remission but I knew something was not right.  We didnt take biopsies at that moment, and unfortunately a flare was truly on the way. Did they take biopsies? if not, maybe the fecal calprotectine you took will corroborate the endoscopic view. so I am thinking it may be very residual inflammation you are experiencing that the endoscopic view couldn't catch. Im am hoping this is the scenario!

second hypothesis is disease activity in other part of the colon or ileum. this already happened to me once, even if I have always had classic endoscopic views and behaviour of UC. If your symptoms persist, i would encourage you to ask for full colonoscopy if possible next time to rule out any other disease activity in the colon or ileum.

3rd hypothesis, concomitant IBS to your UC.


----------



## Wendy M

I had a colonoscopy with biopsies at week 0. Today week 8 was a sigmoidoscopy with biopsies. 
Week 0 showed moderate inflammation. Week 8 showed no inflammation. 
What is residual inflammation?


----------



## SauceySciencey

I keep hearing good things about this. I'm half tempted to go buy some almost out of date supermarket chicken, sneak it into the lab and grow the damn bugs myself.


----------



## Lady Organic

thats awesome Wendy! the biopsies they took again will reveal if you have or not remaining disease activity from the end of your flare that is so minor it cant be seen with eyes during the rectoscopy.


----------



## David

That's amazing that there wasn't any visual inflammation Wendy, hopefully the biopsies show no microscopic inflammation.  Now here's to your symptoms catching up to that!


----------



## Om3ga1

Now if we can get this deal approved in the States.


----------



## xeridea

Here's a recent study which reinforces the role of AIEC in CD. 

Their findings suggest that AIEC may play a greater role in ileal CD than ileal-colonic or colonic CD. Additionally, it was interesting that they suggest a greater prevalence of ExPEC, or extra-intestinal pathogenic E. Coli in CD patients rather than commensal E. Coli strains.


----------



## Wendy M

A new development.  I have had a cold for a week, fairly ugly with a sore throat, cough, runny nose, headache... However Wednesday morning I woke up with an eye that was very red and sore and then Thursday, both eyes. The whites of my eyes are very red ( looks lovely). Anyone else with the cold that I know of does not have this symptom.  I'm thinking, like the cold sore I had, that it is immune system, SSI related.  Any thoughts?


----------



## xeridea

Wendy M said:


> Wednesday morning I woke up with an eye that was very red and sore and then Thursday, both eyes.


Did you have gunky discharge when you woke up in morning? If so it could be bacterial pink eye. Pretty contagious and quite frequently involves both eyes. There's also a viral pink eye and allergic pink eye, and these typically have clear discharge. Probably worth a trip to doctor as the bacterial kind is very treatable with antibiotic drops that will clear it up within 2 or 3 days.


----------



## xeridea

"Life Altering Treatment" -- SSI in the news.


----------



## Lady Organic

Hi Wendy, go see a optometrist asap. Eye doctor who can make a diagnosis. They take emergency patients in stores that sell glasses. Pink eye, Uveitis, episcleritis, or whatever it may be, go check it out to be safe!


----------



## David

I agree with  Lady Organic but I would suggest an opthamologist instead.


----------



## Wendy M

Thanks.  I did talk to the pharmacist and he thought it was just from my sinuses being blocked due to my cold. As I don't like to take oral medications he suggested nasal spray. I have used that since Fruday night and it has definitely helped.I will certainly keep on top of it and go see someone asap if needed.


----------



## David

xeridea said:


> "Life Altering Treatment" -- SSI in the news.


Great story.  Hopefully we see lots of stories along those lines in the coming years.


----------



## Lady Organic

xeridea said:


> "Life Altering Treatment" -- SSI in the news.


from the article : ''A colectomy – surgery to remove all or part of the colon – was recommended.I was starting to feel a little better and I didn’t feel I needed that yet,” he recalled. “There was an opening for the surgery and they pushed pretty hard for it, even having me talk to a psychologist about why I didn’t want it.”

So happy the SSI trial saved the guy's colon. We must never give up hopes, the future is bright and i am sure many other trials are currently saving a lot of organs.


----------



## rollinstone

I just want this thing to be fast tracked so badly


----------



## worriedboy

Did they say when they are going to publish results from phase II ?


----------



## rollinstone

worriedboy said:


> Did they say when they are going to publish results from phase II ?


I think early next year


----------



## Om3ga1

rollinstone said:


> I just want this thing to be fast tracked so badly


That makes 2 of us.


----------



## Wendy M

Week 10 shot tomorrow.  My cold is slowly getting better, as well as my eyes.  I did go see the eye doctor Friday just to ease my mind.  He said all was well and they should be completely better in a week.  I am still slowlyyyy seeing improvement.  One interesting thing is I have had a sore stomach, not like regular cramping...more like tender as if I was hit.  I'm taking that as a SSI effect, that as things become more "normal" there is some pain from the changes.  
Apparently a new component of the trial is that when I measure the rash from the shot if it is too small I increase the dose of SSI I give myself.  What's everyone's thoughts on a higher dose? Better?


----------



## Lady Organic

:cool2::cool2::cool2::cool2:NEWSLETTER from Qu Biologics this morning::cool2::cool2::cool2:

Qu Biologics Completes Enrollment of Randomized Clinical Trial in Crohn's Disease

Vancouver, British Columbia -  November 24, 2015 -  Qu Biologics Inc., a biotechnology company developing Site Specific Immunomodulators (SSIs) that aim to restore normal immune function in the targeted organ, announced that it has completed enrollment of its QBECO-01 Crohn's disease clinical trial, with top-line data expected in late 1Q 2016.

Qu Biologics' QBECO-01 is a 68-patient Phase 1/2 randomized, double-blind, placebo-controlled clinical trial in patients with moderate-to-severe Crohn's disease. The investigators in the study include gastroenterologists Dr. Brian Bressler (Gastrointestinal Research Institute, Vancouver, BC), Dr. Richard Fedorak (University of Alberta, Edmonton, AB), Dr. John Marshall (McMaster University, Hamilton, ON), Dr. Remo Panaccione (University of Calgary, Calgary, AB) and Dr. Jeffrey Axler (Toronto Digestive Disease Associates, Toronto, ON).

QBECO SSI, derived from components of inactivated E. coli, is designed to restore normal immune function in the GI tract. Qu Biologics' Founder and CEO, Dr. Hal Gunn, stated, "Completing enrollment in QBECO-01, our lead development program, is a critical milestone for our company. There is a significant unmet need for improved therapies for inflammatory bowel disease (IBD) - Crohn's disease specifically - and we hope that QBECO SSI, which is designed to restore normal immune function rather than simply suppressing the immune system, will offer a superior alternative to existing therapies." He added, "We look forward to unblinding our top-line results in late 1Q 2016, with complete results by mid-2016. Importantly, we recently initiated a complementary open-label Phase 2 study in patients with moderate-to-severe ulcerative colitis, as well as commercial-scale cGMP production of QBECO, laying the groundwork to begin pivotal studies in IBD in 2017."



Coming soon! I cant wait!!!!


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## Om3ga1

So ready to do this. :dance:


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## SauceySciencey

If they get above 45-50% response and beat Crohns and Hursts use of dysentery serum in the 1920s/1930s, I'll really start to get interested.


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## David

SauceySciencey said:


> If they get above 45-50% response and beat Crohns and Hursts use of dysentery serum in the 1920s/1930s, I'll really start to get interested.


It's going to be interesting, for sure.  Let's hope SSI are a game changer.


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## Robrich

Saucy thanks for the reference to Hurst.  Hadn't heard of that before.
Found an Interesting article re Crohns 
http://www.biomedcentral.com/content/pdf/1471-230X-11-57.pdf


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## SauceySciencey

Yes it's quite interesting, a colleague at work (not a GI, but an immunologist who works on cancer vaccines) put me onto the idea. He says it's the same with cancer, there's work way back then that just stopped due to technology, other things coming along that looked more promising. That's all changed now, all the big pharmas are rushing to develop immune based therapies for cancer. Money money money =D


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## David

Congratulations to Qu Biologics for filling the Crohn's trial.  And thank you to the members of this community for coming together to help make that happen.  Make no mistake, this community played an instrumental role in helping spread the word so that this potentially game changing treatment can one day see the light of day.

Thank you all.

Hopefully the UC trial gets filled quickly as well


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## Om3ga1

rollinstone said:


> I just want this thing to be fast tracked so badly


Ditto


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## David

Cmac?  Wendy?  How are you two feeling?


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## CMac

Hey everyone. It has been a while since I have written about how I have been. So where do I begin...

I would have to say that I have gone thru hell and back with my illness. About 3 weeks ago I experienced severe pain in my abdomen that radiated to my back, the pain hurt so much that I took myself to the hospital to be diagnosed with Pancreatitis. About 4/5 years I had an acute pancreatitis attack that was no where near the severity of pain that this one was. The cause back in the day was unknown. This time my lipase levels were up to 500 (16-65 is normal), and again the cause it unknown. No I am not an alcoholic.

Also my hemoglobin and Iron levels have never been worse. Hemoglobin was 85 (135-170 is normal range) and my Ferritin level was 5.. I have not had any blood in my stool for over 4 weeks now which is why the Hemoglobin is a concern. These blood levels are not the only ones out of range, but my most concern.

It has been about 3-4 weeks now that all of this has happened, I am currently receiving Iron infusions once a week for 3 weeks, which will hopefully boost my hemoglobin. I do feel better from the episode that I had, no more pancreatitis pain. I am tired and weak and have had to stop working as I work in the trades and it would not be safe.

So to sum things up, I do believe that the SSI treatment is helping my colitis symptoms. BM's have dropped to an average of 7 a day (15-20 was the norm), I have not seen blood in my stool for weeks and my stool if better formed than it use to be (could be better), also the urgency to go has improved, I've actually made it to the washroom without any accidents for the past 4 weeks!!!! The million dollar question for me is whether or not the drug has effected the other issue that I am having, or are they completely unrelated?

Also today was my week 8 appointment which consists of blood work, flex sig, stool sample, urine and all that. At the start of the trial I was able to view my own scope and was shocked at how bad things looked, I watched my scope again today and could tell that there was an improvement. It was not a drastic change but better than it looked before. 

I tried to explain things as short and sweet as possible, feel free to ask any questions!


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## Wendy M

Sorry to hear things are not going well for you CMac. Hope you start to feel better soon. Glad at least the colitis symptoms are improving. 
I am holding steady with my symptoms. My symptoms were not as bad to start with. To recap,  since starting the trial I have seen improvement in :
Less pain and nausea- 90% gone
Better form probably 3/4 of the time
Less urgency- 90% of time
Biggest change I am looking for still is frequency - still up to 4 times per day( which I know isn't bad in the big picture,however that can put me in the bathroom for up to 2 hours and of course the uncertainty of when is always an issue).
I think I am still improving, just very slowly. Still hoping for remission.


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## Wendy M

So some interesting news.  I went to see my gastroenterologist yesterday. ( Dr Bressler, I switched to him from my original gastro about 7 months ago- finally got into see him after a one year wait). He is the lead doctor in the trial. I was lucky to get in to see him as he is the top guy.  
He told me that the SSI had done what it was suppose to, I have no UC at this time. However I am still having some symptoms.  He stated that they are being caused by something else ie IBS. So the SSI won't improve my symptoms anymore because it only works on the UC. Therefore we are trying some other things.  First he gave me some cream, as I have a painful fisher that we need to get fixed before anything else.  So I see him again in 2 months and hopefully it is healed by then.  I am continuing with the SSI of course as I want to keep where I am with the UC.  So as great as this news is it's a little frustrating to have to try and figure out what will work for the symptoms I still have.  I do see a great naturopath as well and am seeing her on Tuesday for any ideas to stop the continuing symptoms.


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## Lady Organic

Great news! hopefully you 'll find a way to manage those symptoms.

So this means your biopsies came out normal?


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## rollinstone

Great news, what is your diet like? Have you tried fodmaps? That's supposed to be great for ibs


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## Nilassie

Hello everyone, stumbled upon this thread when reading up on the SSI treatment.  I'm #6 in this UC study and have just passed the 4 week mark.  Though I 'think' my symptoms have improved in terms of frequency, its fairly minor and could also be just positive thinking and a decent couple of days.  Still seem to be bleeding similar to before unfortunately and worried that means this isn't working for me like it has for other folks.  For those who did stop bleeding, how quickly did that occur?  Also wondering if speed of response is linked at all to where the disease is predominantly active in the colon.  I'm affected up to 32 cm.....and worst part is higher up.  
Thanks for sharing everyone.


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## Lady Organic

Hi Nilassie and welcome! Hopefully you we see some results soon! let us know how you go and about your medical fallow ups!


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## David

Hi Wendy and Cmac, it's been a few weeks so I thought I'd check in and see how you are 

Nilassie, welcome to the community!  I hope things begin to improve for you soon!  Either way, thank you for having the strength to partake in this trial and further such important scientific research.


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## Wendy M

Hi all sorry been off line with Xmas...  So I had an appointment with the trial this Thursday for a check up and sigmoidoscopy.  Unfortunately I had to cancel as I have had a stomach bug since Saturday night.  Pretty ugly, threw up in the middle of the night, was achy, very nauseated and running to the bathroom since then. Just started feeling a little better today.  
I have been using the prescription I got for the fisher and it seems to slowly be getting better. So now I've started the next step the doctor suggested.  5 Metamucil capsules at bed time with as little water as possible. I had only done it for a few days prior to getting sick, and stopped for now until I feel better.  
On a side note the new procedures for the study have been approved. So the next time I go they will randomize the dose again and I will end up with no treatment, the same or a different dose. Just want to stay the same at this point.  
David did you say that we don't have to accept the changes?
As asked: my diet is very strict. I was on the SCD for many years.  Now I see a naturopath and follow her instructions.  It is done through a blood test.  Up until about a year ago I was only allowed about 25 foods.  I have been able to slowly add a few more over time.  
Hope everyone else is seeing some improvement.


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## Wendy M

So I was able to go for my appointment and sigmoidoscopy last Tuesday.  Everything is great and shows no sign of UC.  My sigmoidoscopy was perfect, looks like a person who's never had UC. As great as that is I'm still having symptoms so that isn't so great.  With the new randomization I stay at the same dose but go from every other day to once a week.  If I flare then I am out of the trial.  Not happy about this at all. I just wanted to stay with the same as I have been doing since everything was going well.  I am actually pretty upset that they changed it and think that it's very unfair to change things after people have started on the trial.  Adds a lot of stress which is never good.


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## David

I'm glad to hear your sig went well Wendy!  It sucks that you're going to have to change things up a bit.    Unfortunately, this is the hard part of early stage trials as the companies have to work through kinks and regulatory issues.  Knowing the folks at Qu Biologics like I do, I have little doubt they feel terrible that they're having to change things up on a few people.  It may be of little solace and stress reduction, but know there is a good chance that the sacrifices you are making may very well make the lives of countless people with IBD infinitely better in the future.

Everyone with IBD should be grateful to people like you who have the strength to go through what you are.

*hugs*


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## rollinstone

Glad to hear your scope was all good, try not to stress, the symptoms are probably lingering ibs maybe due to being ill for a while. If you're scopes came back 100% clear that means the ssi has likely done its job and cleared your body of what was causing the inflammation. Hang in there though and please keep us updated, bless you.


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## tongtol

Hello everyone! I'm a fellow UCer and I just discovered this thread. I figured I'd give some info on how the study treatment has been going for me.

Prior to starting, I had been experiencing an on again/off again flare for about 3 years (prednisone was the only thing that would stop a flare by that point). To qualify I had to let all drugs flush out for a few months, and had to have severe enough symptoms. To be clear, this wasn't the worst I've been, just the least responsive to other meds. My symptoms going into the study were: 

- 15-18 BMs / day 
- lots of rectal cramping 
- plenty of mucus 
- a bit of blood every day in my stool
- formless stool

So not the worst, but month after month (and really, years) certainly made it difficult. I couldn't go out anywhere without immediately feeling an intense cramp and needing a washroom within 10 seconds distance from myself.

The timeline and symptoms for my SSI experience so far are as follows:

- Study therapy began in mid october
- Felt much better the day after the first injection. a solid BM. was honestly blown away.
- Following day I had a return to previous symptoms. assumed the previous day was psychological. apparently this has occurred with other patients though.
- 6 weeks after starting I started noticing positive signs of recovery.
- 8 weeks in I had 2-5 BMs a day, mostly solid, though snakey looking stool, accompanied by mucus.
- A week or two following I started to decline again.
- Week 14: bowel movements returned to 10-14 territory. Majority are mucus-like, either white or brown and possibly more mucus than I've ever seen during BMs. Some of my BMs are more solid. I occasionally have diarrhea. No blood. Some cramping. Urgency has returned, but not quite as bad as before I started.

I also had my week 16 scope on week 14. results indicated that I had improved from "moderate" disease to "mild" disease despite my symptoms. Another thing to note is that Qu had informed me that my symptoms seemed to be in line with many other UC patients where the first 3 months or so were 2 steps forward, 1 step backward. 

Unfortunately at my last visit (which was my scope day) I was informed that the study protocol had changed and that I would be randomized again into a different dose or frequency of injection. I was sadly randomized from the highest dose every other day, to the same dose injected once a week. Fortunately they did say if I flared up again I would be bumped back to my previous dose, but I'm a bit worried that now I might just stay well enough not to flare up, but not get better either. Time will tell as I just started the new dose.

Some closing thoughts: I do feel better than when I started despite my symptoms worsening over the 3rd month of treatment. It's not great or pleasant, but mild disease is definitely better than moderate and I can feel it. I'm hopeful things will improve from here, but severity of symptoms in the last month and the change in dose are certainly cause for concern on my end.

Anyway hope the information provides some insight!

[edit] Wendy: Are you sure about being kicked out of the study if you flare? What I was told was that if I didn't qualify as having improved at my week 16 scope, then I would be kicked out of the study. However, after re-randomization, if a flare up does occur, I was told I would be bumped back to my previous dose, not kicked out. This was after my nurse called qu biologics to clarify. You may want to personally contact Qu yourself for the sake of clarity.


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## David

Thank you for sharing your experience Tongtol!  I hope things improve greatly for you going forward.


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## SauceySciencey

Thanks for your update tongtol  Hope things keep going for you.

I'm really waiting for these full results to be released. I'm starting to get a sneaky suspicion that this just might work out for a larger number of cases than most treatments do (30-40%). *fingers crossed*


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## David

I'm getting the same feeling Saucey.  If we use clinical remission as an endpoint, I feel far more than 40% might be getting there.  We shall see...


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## SauceySciencey

David said:


> I'm getting the same feeling Saucey.  If we use clinical remission as an endpoint, I feel far more than 40% might be getting there.  We shall see...



I forget exclusion criteria for current treatment? I'm curious to see any results with basic immune suppressants + SSI..one might argue with equal logic for either making SSI more effective by allowing immune clearance to proceed without feedback pushing towards inflammatory conditions (I see people are getting 2 steps forward, 1 step back, suggesting there's a feedback signalling paradigm attempting to shift the area back into inflammation predominance), or whether it might make SSI less effective, since the immune system is suppressed in these conditions. I know Hal Gunn has talked about this treatment as an alternative paradigm...but am curious as to what the result would be in these instances.

They say results released first quarter this year.


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## David

Interesting thoughts Saucey.  I hadn't begun to even ponder the potential of combo treatments with SSI and how it might work.  Let's hope we get to find out


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## tongtol

Yes, it would be interesting to see the effects of combined therapies, though I'm sure it would depend on the type of immune suppressant since you wouldn't want to suppress the part of the immune system that the SSI therapy is trying to activate. 

I think what would actually be interesting is pairing the SSI therapy with a fecal microbiota transplant.

[edit] as far as exclusion criteria go, from what I remember up to 30mg of prednisone was allowed, but everything else had to be flushed out 60 or 90 days before screening.


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## Wendy M

Thank you Tongtol. Some differing information from the nurses.  I re read the new Informed Consent that we had to sign. It states that"participants that are randomly assigned to the no maintenance treatment are eligible to return to their induction treatment dose and schedule if they flare"   It doesn't say anything regarding the weekly treatment. I wondered if you could let me know your nurses name, mine is Maria. (You could private message me if you prefer). We are not allowed to talk to anyone at Qu, as it is a conflict of interest and they just refer us back to our nurse.  
Regarding the exclusion criteria, I believe you just could not be on/ or have been on any biologic. I stayed on all my regular medication.


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## tongtol

Yeah, turns out my nurse got it wrong and received clarification from qu that only those who were randomized to no drug will be able to return to the every other day dose. Patients on a weekly dose will no be able to return to the study. 

Doesn't really make much sense to me honestly.

[edit] I realized my location was set wrong here. I live in Ontario so I'm not sure it would be much use to know my nurse heh.


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## tongtol

Turns out the previous bit was not correct - according to what I just heard back weekly dose patients can go back up to daily if they flare. I guess a case of bad communication!


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## Wendy M

I spoke with my nurse as well. She said that Qu is putting an amendment on the protocol that weekly dose patients will be allowed to go back to every other day dosing if they flair.  She is going to let me know once it has been okay'd by Health Canada.  I think that Qu maybe has bowed to pressure as people were pretty upset(including myself) that we would not be allowed to return to the previous dose if we flared. It did seem odd that if you had been taken off you could go back on, but not from weekly.  I didn't really see what the difference was.


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## tongtol

Yeah, a little strange. 

[edit] It sounds like it was an oversight on their part, not intentional. A detail that slipped through the cracks I guess.


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## SauceySciencey

Bump.

How you guys going?


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## tongtol

Since being reduced to the once a week dose, I've fluctuated in BM frequency quite a bit. For a few weeks my BMs were going between 13 - 17 per day. Then 2 weeks ago out of nowhere I went down to 5 one day, with the rest of the week at 8 per day. This past week it jumped around wildly between 6 and 18 BMs per day. 

There was a pattern for a while, where a day or two after injection I'd see a dramatic increase in BMs, and then fall back to the week's norm. I'm not so sure I'm seeing that correlation lately though.

Also, no blood thus far. I'm not on anything else, including prednisone. Stool quality is usually soft and snakey looking. Not as much mucus as previous months. Rectal cramping is variable, but much better than before I started the trial still. 

So, slight improvements, but one has to wonder if I'd be making faster progress on the alternate day dosing I was on before. October and November were still by far my best months as I was able to get out and get things done. Right now thats just not a possibility unless I pop some imodium (which would taint my numbers for a day or two), and even then that tends to make me feel pretty crummy.


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## xeridea

Qu announced preliminary results today. No hard data, just that the treatment of 68 patients is shown to be safe and demonstrates consistent positive results at 8 and 16 weeks. The trials will continue to move forward and they expect to announce full results in the Fall.


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## Lady Organic

NEWSLETTER: 
Qu Biologics Announces Initial Results in Randomized, Placebo-Controlled Crohn's Disease Clinical Trial:

Vancouver, British Columbia - March 21, 2016 - Qu Biologics Inc., 

an immunotherapy company developing Site Specific Immunomodulators (SSIs) for cancer and other inflammatory diseases, announced initial results from the QBECO-01 study, a 68-patient randomized, placebo-controlled clinical study for the treatment of moderate-to-severe Crohn's disease.
Based on the Week 8 and preliminary Week 16 results, QBECO SSI appears safe and well-tolerated and demonstrates consistently positive trends throughout the treatment period of the trial, successfully establishing proof-of-concept in Crohn's disease and supporting continued development of QBECO SSI in inflammatory bowel disease.

Dr. Hal Gunn, CEO of Qu Biologics stated, "The positive trends observed across patient groups at Week 8 and Week 16 support the further assessment of SSIs as a therapeutic alternative to current treatments which suppress immune function."

Jim Pankovich, Qu Biologics' VP, Clinical Operations and Drug Development, added, "We are encouraged with the results of the trial, which will help to optimize the design and implementation of subsequent inflammatory bowel disease trials. Full results from the QBECO-01 study, including an assessment of the potential for sustained remission 8 weeks after completion of SSI treatment, are expected in the fall."

Qu Biologics' QBECO-01 study is a randomized, placebo-controlled, double-blinded clinical trial involving 68 participants with moderate-to-severe Crohn's disease. Participants were randomized (1:1) to treatment with QBECO SSI or placebo. The objectives of the study are to evaluate the safety and effectiveness of QBECO SSI for the treatment of Crohn's disease. The clinical study is taking place at four Canadian sites, in Vancouver, Edmonton, Calgary and Toronto.


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## xeridea

Qu announced closing another $4 million in a new funding round. This will allow them to expand their CD and UC trials, and that's pretty great news!


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## SauceySciencey

I find the promotional picture from that announcement to be interesting - considering there happens to be an ingredients list for the SSI vaccine itself, minus the phenol. Oops.


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## Scared1

Trevor said:


> Oh boy. Not good news...
> 
> Crashed and burned about 8 weeks after the end of the trial. Actually pretty spectacularly. No more job, back on Pred and just waiting for the Humira
> 
> Sorry, guys.
> 
> If you're reading this and about to start or considering starting the SSI, it did some good stuff for me. It sucks it couldn't keep me where I was once I stopped taking it but this is where I was before so it's not that it made me worse.
> 
> I'll try and be around more. Been a rough go the last few weeks.


Hi Trevor, I hope all has been well with you! I am sorry to hear what had happened. Did the onset happen gradually or right away and were you on anything for those 8 weeks?


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## Wendy M

Hi all.  Haven't checked in recently as everything is still the same. Interesting change in the protocol, again. I am seeing the nurse today for my week 36 check in. When she called she said that they have changed the protocol back to the way it was. Therefore I will be going back to injections every other day rather than once a week.


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## Scared1

Wendy M said:


> Hi all.  Haven't checked in recently as everything is still the same. Interesting change in the protocol, again. I am seeing the nurse today for my week 36 check in. When she called she said that they have changed the protocol back to the way it was. Therefore I will be going back to injections every other day rather than once a week.


Hi Wendy,
Thanks for the reply! You are on this trial? Are you doing good on it at all?


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## David

Wendy M said:


> Hi all.  Haven't checked in recently as everything is still the same. Interesting change in the protocol, again. I am seeing the nurse today for my week 36 check in. When she called she said that they have changed the protocol back to the way it was. Therefore I will be going back to injections every other day rather than once a week.


Interesting that they're changing back.  Did they say why?

Thanks for the update!


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## Wendy M

Scared1 
Yes I have been on the trial since September 15. I have had good success in that my last scopes show no sign of disease.  However I am still having some symptoms.  
David
They haven't told me why but I will ask my nurse later today at my appointment.


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## Scared1

Wendy M said:


> Scared1
> Yes I have been on the trial since September 15. I have had good success in that my last scopes show no sign of disease.  However I am still having some symptoms.
> David
> They haven't told me why but I will ask my nurse later today at my appointment.


Thank you Wendy - please keep us posted, I would love to hear more. This trial is under Bacterial Vaccines and I think the whole opportunistic infection type of premise for Crohn's would be validated even more based on the success of this trial amongst others (i.e. MAP stuff going on). 

That's weird that you are having symptoms - did they do any biopsies at your last scope?

Thanks again for the info!


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## David

Thank you Wendy.

What are your current symptoms?


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## SauceySciencey

Thanks Wendy, we need more people like you stepping up for these tests to get through the murkiness! I hope things work out (for us all!)


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## Scared1

There is a clinical trial currently going on which seems to be looking at the use of antibiotics to treat AEIC? Not sure if this would tie in with the vaccine but the estimated completion date is 2020? This seems to be the AMAT version for AEIC....

https://clinicaltrials.gov/ct2/show/NCT02620007?term=crohn's+e.coli&recr=Open&rank=1


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## SauceySciencey

I wish they'd hurry up - I went into one of my mini flares at work last night - and I was supervisor with 5 new people, so they were a bit uncomfortable with me walking around their desks checking their work holding an ice pack to my stomach to offset the swelling and since I was supervisor I couldn't go home sick since I was the senior in the entire building and everyone would have to go home haha. Better this morning though. No eating for a day or two. But yeah, they need to hurry up.


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## Scared1

SauceySciencey said:


> I wish they'd hurry up - I went into one of my mini flares at work last night - and I was supervisor with 5 new people, so they were a bit uncomfortable with me walking around their desks checking their work holding an ice pack to my stomach to offset the swelling and since I was supervisor I couldn't go home sick since I was the senior in the entire building and everyone would have to go home haha. Better this morning though. No eating for a day or two. But yeah, they need to hurry up.


I am sorry Saucey, that really sucks. How long have you had Crohn's and what med's are you on? I can't imagine how horrible that must be - just doing your daily tasks and that in of itself is a struggle..:-( This year I think - honestly based on the timelines, we will get good information - either pro MAP (via Redhill studies should be presented end of the year at least interim) or show they failed (at least we will know) and the SSI is supposed to have something presented.  I check these everyday - while my husband is asymptomatic. it breaks my heart reading all these struggles everyday:-(


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## SauceySciencey

Scared1 said:


> I am sorry Saucey, that really sucks. How long have you had Crohn's and what med's are you on? I can't imagine how horrible that must be - just doing your daily tasks and that in of itself is a struggle..:-( This year I think - honestly based on the timelines, we will get good information - either pro MAP (via Redhill studies should be presented end of the year at least interim) or show they failed (at least we will know) and the SSI is supposed to have something presented.  I check these everyday - while my husband is asymptomatic. it breaks my heart reading all these struggles everyday:-(


Thanks, it's all good. The boss is very accepting of it - she knows sometimes I need to disappear and go into the shower (for some reason, cold showers have a nastily positive painkilling effect on me). Well, they could show that MAP has nothing to do with crohn's, but it could still turn out that the redhill clinical trial has positive results treatment wise.  I'm leaning towards it being better than placebo - either way, it's another bullet in the arsenal for people 

Currently 6 mg budesonide (roughly, it wavers), 100 mg azathioprine. And humira once fortnightly for the ankylosing spondylitis, which it does wonders for. I'm hoping a magic bullet comes along soon, I spent 8 years training to be a medical researcher, I'm supposed to be in a lab curing cancer, according to my mother 

Hopefully your hubby can stay symptom free a little while longer


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## Scared1

SauceySciencey said:


> Thanks, it's all good. The boss is very accepting of it - she knows sometimes I need to disappear and go into the shower (for some reason, cold showers have a nastily positive painkilling effect on me). Well, they could show that MAP has nothing to do with crohn's, but it could still turn out that the redhill clinical trial has positive results treatment wise.  I'm leaning towards it being better than placebo - either way, it's another bullet in the arsenal for people
> 
> Currently 6 mg budesonide (roughly, it wavers), 100 mg azathioprine. And humira once fortnightly for the ankylosing spondylitis, which it does wonders for. I'm hoping a magic bullet comes along soon, I spent 8 years training to be a medical researcher, I'm supposed to be in a lab curing cancer, according to my mother
> 
> Hopefully your hubby can stay symptom free a little while longer



I really think we are close to a bullet of some sort, I honestly think the biggest hurdle to a cure or anything else is the Crohn's is an autoimmune mindset only. Being someone who I self diagnosed as OCD -and currently since my husband as been diagnosed (who has been asymptomatic always, as of last year before medicine - the basis of his diagnosis is the inflammation but that is another story), I have read soooo many articles, scientific journals and videos discussing the topic and then I read something about it being autoimmune and it annoys me because there is a clear difference  between Crohn's and all these other autoimmune diseases, yet people disregard that for some reason. But honestly, I think within the next few years, something big will happen for sure - all thanks to researchers and people who are willing to think outside the box or popular conventions of that time....I hope in the meantime you feel much much better Hang in there!


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## Wendy M

So the SSI nurse says that the reason we get to go back to the original dosing is because patients were relapsing from remission when they were taken from every other day injections to once a week. 
My symptoms are: 
(Worst)is incomplete evacuation, which effects frequency. And makes for a lot of time spent in the bathroom. 
frequency (2-4 times per day.) I know that's not bad for colitis but still not great.  Unknown when etc so can't plan things without concern.
Still occasional diarrhea.  
So similar symptoms as prior to Ssi. Very frustrating as I always seem to only get to a certain point and then no more improvement.  
As I have said before the closest to remission I have come was on low dose naltrexone .  I am still taking it but it definitely isn't working like it did for a while. 
I had always stayed away from the Biologics but had decided to try entevyo if the ssi didn't work. But the doctor said because my last scope didn't show any signs of disease there was no point in trying it.  So I'm not sure what to do now.  
They did take biopsies on the scope but I haven't heard anything back. 
I am scheduled for a colonoscopy in October.


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## Scared1

Thanks Wendy for the update! I am so sorry you are still having symptoms:-(....Could food or some other reasons perhaps be causing this? That is so strange you have symptoms but no apparent active disease....do you think that the dosage - every day or every other day would affect how the long term impact is after the person stops SSI? Maybe your body just needs extra long to clear out the "infection" or pump your immune system so that it can handle it itself later on? 

Sorry for the pain, please keep us posted...I hope it gets better for you soon!


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## tongtol

I guess I'll give an update as well.

- Before starting SSI I was going between 15-18 times a day, with blood in my stool probably once a day and lots of painful rectal cramping. not the worst flare i've had, but the longest i've had.

- A month after starting I started to get better. after a month I was down to between 2-5 bowel movements a day that were much more solid than i've had in a long time. much less pain.

- A month after that I was reversing course back to around 10 urgent bowel movements a day. Shortly after I was randomized off of the alt day dose to once a week. Within a month and a half I relapsed and was hitting randomly between 12-18 BMs a day with blood here and there, lots of cramping, and mucus. 

Having gone back to alt day dosing seems to have helped some what but its been a rocky road again and I've been told UC seems to be a rockier road than crohns with a lot of back and forth slow improvement. Unlike Wendy I never got rid of my inflammation though. Scopes showed less inflammation than when i started, but nonetheless it was a minor improvement. unfortunately that scope was also timed at a point where i had regressed so its hard to say what i looked like at the peak of my improvement. 

In the last month I had gone down to about 5-8 BMs that were starting to look a bit more solid, but then it climbed back up to the 10 more urgent and mucus filled BMs with lots of cramping and gas and what not. One problem is that the SSI induces a type of inflammation to kill off any infection, so as a patient its really hard to know if this inflammatory response is my disease or the ssi doing its job. having lost several months to being on once a week was also a huge set back for me. it's hard to say whether or not that time off means i've essentially started from square one with the treatment again, and now with much less time than I initially thought I would have.


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## Scared1

tongtol said:


> I guess I'll give an update as well.
> 
> - Before starting SSI I was going between 15-18 times a day, with blood in my stool probably once a day and lots of painful rectal cramping. not the worst flare i've had, but the longest i've had.
> 
> - A month after starting I started to get better. after a month I was down to between 2-5 bowel movements a day that were much more solid than i've had in a long time. much less pain.
> 
> - A month after that I was reversing course back to around 10 urgent bowel movements a day. Shortly after I was randomized off of the alt day dose to once a week. Within a month and a half I relapsed and was hitting randomly between 12-18 BMs a day with blood here and there, lots of cramping, and mucus.
> 
> Having gone back to alt day dosing seems to have helped some what but its been a rocky road again and I've been told UC seems to be a rockier road than crohns with a lot of back and forth slow improvement. Unlike Wendy I never got rid of my inflammation though. Scopes showed less inflammation than when i started, but nonetheless it was a minor improvement. unfortunately that scope was also timed at a point where i had regressed so its hard to say what i looked like at the peak of my improvement.
> 
> In the last month I had gone down to about 5-8 BMs that were starting to look a bit more solid, but then it climbed back up to the 10 more urgent and mucus filled BMs with lots of cramping and gas and what not. One problem is that the SSI induces a type of inflammation to kill off any infection, so as a patient its really hard to know if this inflammatory response is my disease or the ssi doing its job. having lost several months to being on once a week was also a huge set back for me. it's hard to say whether or not that time off means i've essentially started from square one with the treatment again, and now with much less time than I initially thought I would have.


Thank you for the update! This is very informative and very appreciated...do you feel there is a interim period where the vaccine is helping your body have a "normal" reaction meaning the inflammatory is killing off the bad bacteria if you will and so that is what you are experiencing? And in your opinion, do you think that the length of time you have had UC may also be a factor? Maybe longer = more time to adjust and work?


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## tongtol

It's possible that the number of years I've had UC might be a factor. I had UC for 9 years and while it started as pan-colitis, most of my flares are located primarily in the rectum and sigmoid colon gradually tapering off in intensity.

As far as what I think is going on? its really hard to say, I'm not a doctor or researcher. I like to think that the amount of mucus I see is directly related to my body having an inflammatory response that is doing some good, but since we're in effect pioneers of this study there's nothing to compare to.

My guess is that the SSI triggers my body to look for something to kill, and when it finds it, I go into an inflammatory phase. When it finishes killing off that patch of infection, it goes back into a lull. The continued usage of SSI means my body continues to hunt for something, and when it finds another patch of infection it goes back into attack mode. 

That's just a wild guess though. I have nothing to base that on really.


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## Scared1

tongtol said:


> It's possible that the number of years I've had UC might be a factor. I had UC for 9 years and while it started as pan-colitis, most of my flares are located primarily in the rectum and sigmoid colon gradually tapering off in intensity.
> 
> As far as what I think is going on? its really hard to say, I'm not a doctor or researcher. I like to think that the amount of mucus I see is directly related to my body having an inflammatory response that is doing some good, but since we're in effect pioneers of this study there's nothing to compare to.
> 
> My guess is that the SSI triggers my body to look for something to kill, and when it finds it, I go into an inflammatory phase. When it finishes killing off that patch of infection, it goes back into a lull. The continued usage of SSI means the body continues to hunt for something, and when it finds it again it goes back into attack mode.
> 
> That's just a wild guess though. I have nothing to base that on really.


Thank you though - I am really interested in this trial and I really appreciate your first-hand experience. Please keep us posted, and I hope that your symptoms will subside....:-(


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## tongtol

Thanks. It's been a 4 year run of constant flares for me, so I'm definitely ready to get my life back and maybe see some more sunshine!

Edit: What's most frustrating about this is that my Colitis never gets beyond "moderate", so it always seems treatable yet its bad enough that the urgency prevents me from going anywhere or concentrating on much of anything. Sadly one day ASAs stopped working, drugs like 6mp had no effect, and anti TNF drugs didnt do a thing for me either, so outside of entyvio, i'm not seeing a lot of options from a pharma perspective.


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## Scared1

tongtol said:


> Thanks. It's been a 4 year run of constant flares for me, so I'm definitely ready to get my life back and maybe see some more sunshine!
> 
> Edit: What's most frustrating about this is that my Colitis never gets beyond moderate, so it always seems treatable, but unfortunately one day ASAs stopped working, drugs like 6mp had no effect, and anti TNF drugs didnt do a thing for me either.


That's the thing with this disease - I just don't believe it can be ONE underlying cause, waaay to much variability and too much differing patient reactions and successes with the drugs that are available. I mean, for diabetes I - you take insulin it works consistently, etc...yet for Crohn's or UC - just so frustrating and different. Have you tried diet changes maybe? 4 years of consistent flares, my heart hurts for you - that is horrible but it seems like you are pushing through - that will make your day in the sunshine when it arrives that much better


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## tongtol

My GI told me that Crohn's and Colitis are more likely a spectrum of something like a 100 smaller diseases, with each person having a handful of those, which would explain the variability in effectiveness of treatment.


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## Scared1

Wendy M said:


> So the SSI nurse says that the reason we get to go back to the original dosing is because patients were relapsing from remission when they were taken from every other day injections to once a week.
> My symptoms are:
> (Worst)is incomplete evacuation, which effects frequency. And makes for a lot of time spent in the bathroom.
> frequency (2-4 times per day.) I know that's not bad for colitis but still not great.  Unknown when etc so can't plan things without concern.
> Still occasional diarrhea.
> So similar symptoms as prior to Ssi. Very frustrating as I always seem to only get to a certain point and then no more improvement.
> As I have said before the closest to remission I have come was on low dose naltrexone .  I am still taking it but it definitely isn't working like it did for a while.
> I had always stayed away from the Biologics but had decided to try entevyo if the ssi didn't work. But the doctor said because my last scope didn't show any signs of disease there was no point in trying it.  So I'm not sure what to do now.
> They did take biopsies on the scope but I haven't heard anything back.
> I am scheduled for a colonoscopy in October.


Hi Wendy,
How are you doing? Any updates on your status?


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## Lady Organic

So I have read on Qu Biologics website that Phase 1 for UC is closed for recruitment and that a Phase 2 will start...
Anyone with any other updates or any news from people on this trial???


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## tongtol

I'll give my take on the trial. I think the treatment helped, but unfortunately due to the design of the study, I ended up being taken off the effective dose for several months and regressed close to pre-trial conditions. I was put back on the original dose because of this but had a much smaller window of opportunity to recover fully. That being said, I went from 18 bowel movements + cramping and blood per day to about 2-4 now, with the occasional 5. I'm definitely not in remission, but theres no blood, and the pain is basically not there anymore. just mild discomfort during the first few hours of the day typically.

So, I think there's promise, though it sounds like the treatment probably works better for crohn's than colitis considering how much faster the drug becomes effective for people. Also I think the reason for the trial closing and coming back with a phase 2 is to redesign a much more rigorous trial. I think perhaps its the kind of thing that might also be combined with another treatment, like say FMT, for a more guaranteed result, and perhaps a faster result.

Anyway, it was a long and rough journey. I went through repeated weeks long cycles of 2 steps forward, 1 step back, which got pretty discouraging since it makes positive progress seem so much less significant. It's hard to see the forest for the trees when you're parked on the porcelain throne for a year, but at least I no longer have to go to the washroom 18 times a day!


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## Lady Organic

Thanks for sharing Tongtol. I am sorry you didnt get the full package treatment, seems like it helped in part though. 2/2 UC acheived continuing remission under SSI compassionate initial trial, so I am hoping it can work as much for CD and UC.


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## Scared1

tongtol said:


> I'll give my take on the trial. I think the treatment helped, but unfortunately due to the design of the study, I ended up being taken off the effective dose for several months and regressed close to pre-trial conditions. I was put back on the original dose because of this but had a much smaller window of opportunity to recover fully. That being said, I went from 18 bowel movements + cramping and blood per day to about 2-4 now, with the occasional 5. I'm definitely not in remission, but theres no blood, and the pain is basically not there anymore. just mild discomfort during the first few hours of the day typically.
> 
> So, I think there's promise, though it sounds like the treatment probably works better for crohn's than colitis considering how much faster the drug becomes effective for people. Also I think the reason for the trial closing and coming back with a phase 2 is to redesign a much more rigorous trial. I think perhaps its the kind of thing that might also be combined with another treatment, like say FMT, for a more guaranteed result, and perhaps a faster result.
> 
> Anyway, it was a long and rough journey. I went through repeated weeks long cycles of 2 steps forward, 1 step back, which got pretty discouraging since it makes positive progress seem so much less significant. It's hard to see the forest for the trees when you're parked on the porcelain throne for a year, but at least I no longer have to go to the washroom 18 times a day!


Thank you for sharing, I really appreciate getting any information about this treatment - I am eagerly waiting for it for my husband to give it a try, hopefully within the next 5 years it will have passed all the phases.

If you don't mind me asking - are you still at 5 times a day even after you are done with the treatment? Are you taking any other medication?


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## tongtol

I started entyvio about two months ago, about a month and a half after I stopped the trial. I feel roughly the same since I stopped the trial, and considering entyvio takes a minimum of 4 months to kick in for most people I'd say the trial must have had a lasting effect on me. Usually by this point I'm starting to flare pretty significantly. It's possible the entyvio is already doing something but it's quite rare for it to kick in so quickly (sometimes it takes up to 9 months for people), and like I said, it's not like I feel any different from when I exited the trial. 

Hopefully the next trial gives them enough useful data that it can be the last trial, assuming its very effective at the dose and duration they administer it for. But yeah its probably at least 5 years away from coming to market, so I hope your husband is able to find something that works for him in the mean time!


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## Lady Organic

Article on two Crohn's patients who received the compassionate SSI trial:
http://www.ourperth.ca/community-st...nts-urge-participation-in-ssi-clinical-trial/


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