SSI Vaccine Trial

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

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.
 
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.
 
Well, I just landed in Stockholm, Sweden with the SSI and haven't felt anythinh yet. But today is my fourth injection
 
Great deal Bees! I loved Vancouver. How early did you feel any difference in your health? Please collaborate on your journey!
 
Seb, did they for sure give you the drug and not placebo on account of the traveling? Hope you start feeling good soon!
 
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.
 
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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!
 
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!
 
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!
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:dance:
 
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'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.
 
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.
 
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.
 
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.
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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.
 
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.
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Actually all 10 showed improvement, 7 of 10 went into remission, and 4 of those 7 have remained in remission.
 
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
 
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?
 
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.
 
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.
 
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
 
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
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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?
 
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?
 
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 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?
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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.
 
pmitra,

the vaccine might not be working because of where your disease is located. You might have something different than everyone else participating.
 
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.
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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.
 
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.
 
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.
 
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?
 
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.
 
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.
 
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!
 
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.
 
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!
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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.
 
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.
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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.
 
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?
 
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.
 
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.
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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.
 
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.
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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?
 
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.
 
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.
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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.
 
Wendsjoy said:
David, I take 250mg of magnesium oxide
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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 :)
 
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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.
 
Joshuaaa said:
I'm hoping they're all feeling so good they're too busy enjoying life ;p
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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.
 
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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'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.
 
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?
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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?
 
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?
 
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?
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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 said:
A Paleo-ish diet, magnesium, fermented foods and probiotics + sun, sleep, less stress and more exercise. Pump up that immune system!
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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.
 
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.
 
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.
Click to expand...

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

That cold thing, that sounds super promising :)
 
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
Click to expand...
Are you responding well to Remicade?
 
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?
Click to expand...

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.
 
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
 
+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.
 
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
 
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.
 
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
 
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.
Click to expand...
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 said:
Are you on a biologic that is working well for you?
Click to expand...
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.
 
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.
 
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.
Click to expand...
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.
 
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.
 
David said:
You do understand that you DO get the real SSI at a certain point even if you get the placebo initially, correct?
Click to expand...
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.
Click to expand...
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.
 
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