Lets talk about poop: FMT as IBD Treatment Clinical Trial.


If you have not read the first post discussing what FMT is and how it might be used for IBD here is the link for it FMT and IBDI also wrote a post discussing types of remission which will help for this post as well check it out ☞ Types of IBD Remission.

Now that we know what FMT is, why it is used and that it could possibly be a treatment for IBD let’s look at a recent clinical trial study. This study was looking at FMT as a treatment for Ulcerative colitis patients who were resistant to conventional therapy. Here is how the trial is set up.

Set up of the trial:

  • 81 patients with active UC resistant to therapy are randomized in this study.
  • 41 patients received a single FMT transplant and 40 patients received the placebo (not FMT) colonoscope infusion on day 1 and then FMT or placebo enema 5 days a week for 8 weeks.
  • Each active FMT enema is derived from 3 to 7 unrelated donors.
  • Patients on corticosteroids had to do mandatory weaning and stopping of the steroids before the study began.
  • The primary endpoint was steroid-free clinical remission.
  • The secondary endpoint was steroid-free clinical remission, clinical response to the FMT, endoscopic remission, quality of life and safety.

Patients either received active FMT or the placebo, which means the placebo patients did not actually get FMT. This is a common way to set up these clinical studies to decide whether FMT was working compared to the patients not receiving the treatment. Let’s look at the results and then I will break it down more.

Results:

  • In the 41 patients receiving active FMT  27% of them achieved the primary endpoint of steroid-free clinical and endoscopic remission of those receiving the active FMT.
  • Compared to the placebo group where only 8% reached this goal.
  • 44% of these patients felt a clinical response to treatment, which means the treatment made them feel better clinically (symptoms) compared to 20% of the placebo group who said they felt better.
  • The 40 patients who received the placebo, at the end of the 8 weeks was offered the active open label FMT treatment. Of those 40 patients, 27% of them achieved the primary endpoint and 46% achieved clinical remission, which is where their symptoms improved and 24% achieved endoscopic remission. These results are in line with those who were not on the placebo, which is good.

 

So if you are looking at the results 27% of the patients who initially received active FMT treatment achieved steroid-free clinical and endoscopic remission and 44% achieved the clinical remission. This was all achieved at the 8-week time point. Again, I discussed remission types ☞Types of IBD Remission.

 

Discussion.

Now, a lot of people look at this and think that 27% is pretty low, which it seems low but consider this. These UC patients were resistant to treatment, which means all conventional therapy was not working for them. They didn’t just achieve remission they achieved steroid-free endoscopic remission when drugs like biologics couldn’t even get them there. Then 44% of the patients achieved clinical remission, which means that FMT actually made their symptoms better! You also have to consider this was at an 8-week time point, which for most clinical trials is the initial time-point for results to be presented to the FDA, but studies will continue further time points every 8 weeks or check at 8 weeks and 52 weeks depending on the trial itself and therapy being investigated. There are also drugs out there on the market with lower success rates than this, it is all about how significant the data is compared to patients not on the drug or treatment (placebo).

 

Now you can’t compare one study to another like I can’t compare this study to say a biologic therapy because there are too many variables at play. In science, we have to do our best to account for specific variables such as target population, age, the number of patients enrolled etc. But what I can say is that this study does show similar results in that the group receiving the FMT showed a significant amount of improvement and remission compared to the placebo group, which tells us that this deserves to be tested further. I do want to see more results from this FMT study at longer time-points because we need to know how long this remission lasts, does the bacterial composition after FMT treatment stops remain the same or will they need to continue giving themselves the enema? We also need a larger patient sample, but you always start with a small sample size and then add more patients in the next phases. These are BIG questions that need to be answered and addressed when it comes to FMT. Basic science of the gut microbiota is a must, and the more we learn about the gut microbiota and how it contributes to disease the better armed we will be in treating certain diseases such as IBD.

Conclusion.

FMT is showing some promising results for IBD which is great, even if it turns out to be a last resort treatment at least it will be something else for patients if it gets all the approval and continues to show efficacy. I know that an enema 5 days a week like they did in this study is pretty intense, but if I was in the position where all the conventional drugs I had taken just were not working anymore I would give myself an FMT enema if it would help. Also, we are learning more and more about the gut microbial composition of these fecal donors due to sequencing, and getting a better picture of what type of bacteria are actually working to achieve these results. We still have a LONG way to go with the gut microbiota and FMT studies, because there is still a lot we just don’t know, but it is becoming clearer every day that being able to manipulate the gut microbiota can offer significant efficacy results in IBD patients.

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References:

600 Paramsothy-Multi Donor Intense Faecal Microbiota Transplantation is an Effective Treatment for Resistant Ulcerative Colitis

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3837253/

https://www.sciencedaily.com/releases/2016/05/160523160429.htm#.V0b_w-syutA.facebook

http://www.gastrojournal.org/article/S0016-5085(11)01506-X/abstract?referrer=http%3A%2F%2Fwww.ncbi.nlm.nih.gov%2Fpubmed%2F22062358