SSI Vaccine Trial

Crohn's Disease Forum

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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.
 
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.
 
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?
 
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 [email protected].

Add this meeting to your calendar!
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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?
 
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/
 
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.
 
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 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.
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Wendy, best of luck to you! Please keep us updated!
 
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.
 
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!
 
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.
 
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.
 
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!
 
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.
 
Hello guys,

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

Thanks :)
 
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!
 
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: )
 
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....
 
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.
 
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.
Click to expand...

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.
 
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.
 
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
 
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
 
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
 
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 :)
 
I went off all medication about a month before going on the trial. I am not on any other meds, ssi only.
 
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
 
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.
 
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*
 
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.
 
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.
 
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.
 
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?
 
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.
 
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.
 
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!
 
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.
 
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?
 
Wendy M said:
Wednesday morning I woke up with an eye that was very red and sore and then Thursday, both eyes.
Click to expand...

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.
 
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!
 
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.
 
xeridea said:
"Life Altering Treatment" -- SSI in the news.
Click to expand...

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.
 
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?
 
: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!!!! :D
 
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.
 
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
 
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 :)
 
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!
 
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.
 
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.
 
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.
 
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.
 
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.
 
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.
 
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*
 
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.
 
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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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*
 
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...
 
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...
Click to expand...


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.
 
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 :)
 
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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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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