A summary of Australia’s Fecal Microbiota Transplant (FMT) study for treatment of Ulcerative Colitis
Through my research of how to heal myself and find the cause (and cure) for Crohn’s and Colitis, I’ve found that medical studies and journal papers are the best source of unfiltered information that’s available to me. However, these studies can be difficult to read through and understand, and as such are not widely available or accessible for the masses. A year ago, the most comprehensive study to date on fecal microbiota transplant (FMT) for treating Ulcerative Colitis came out of Australia. I have yet to see a good summary published anywhere, so I decided to write one up myself!
Please note that since this is just a summary, there are many details that I’ve left out. I tried to put in the most relevant pieces of information in a way that will be comprehensive and relatively easy to understand. If there’s anything you have questions on please post them in the comments. The study abstract and full paper can be purchased here:
Multidonor intensive faecal microbiota transplantation for active ulcerative colitis: a randomised placebo-controlled trial.
Background and comments from Scott:
One year ago, a group of scientists and doctors in Australia published a new study on FMT treatment for Ulcerative Colitis. Preceding this, there have been several studies on FMT therapy for UC, but only two of them were randomized controlled trials. The studies have also differed drastically in method of FMT administration and frequency. Some were administered through a tube through the nose (nasoduodenal), some via colonoscopy, some via enema, and others via a pill. Of the two randomized controlled trials, one gave patients one FMT per week for a total of 6 weeks, and the other gave only two infusions 3 weeks apart.
Leading doctors in FMT and microbiome research have suspected that, while a single FMT infusion may cure a disease like C. Diff, multiple FMT infusions over an extended duration are required to treat and ameliorate a disease like Ulcerative Colitis. (From my personal experience, it took 3–4 weeks of 5x per week FMT treatments to get my UC in remission, and I’ve spoken to people who did it almost daily for 6+ months before achieving full remission.) It has also been suggested that some donors provide better results, or that treatment with multiple donors can increase microbiota diversity and lead to a higher rate of remission. [Source: personal conversations/interviews with doctors, researchers, and specialists in the field.]
Study design (how the study was set up and implemented):
85 patients were enrolled in the double-blind, placebo-controlled trial (neither the patients or the doctors administering the treatment knew who was getting real FMTs and who was getting a placebo). 42 patients received FMTs, and 43 received placebos
All patients received 40 treatments over the course of 8 weeks (5 days of treatment each week followed by 2 days off). FMTs were composed of blended stool from three to seven donors, to increase microbiota diversity. The first FMT was administered via colonoscopy, and the following treatments were self-administered by the patient via enema.
During the study, patients kept a log of their symptoms, and were seen by the doctors approximately every 2 weeks. At the end of 8 weeks, patients received a sigmoidoscopy (endoscopic imaging of the lower part of the colon) to evaluate any change in the colon.
Results:
Clinical remission was evaluated based on self-reported symptoms and a doctor’s analysis of the patient. Of patients receiving FMTs, 44% achieved steroid-free clinical remission. An additional 54% achieved steroid-free clinical response (some improvement, but not full remission). This is total of 98% of patients achieving some form of clinical improvement from FMT treatment. This was significantly more than the placebo group, where only 20% achieved clinical remission, 23% clinical response (43% total)
Endoscopic remission was evaluated based on the findings of a scope (camera photos) of the colon. Of patients receiving FMTs, 12% achieved steroid-free endoscopic remission. 32% achieved steroid-free endoscopic response (some improvement, but not full remission). This is a total of 44% of patients achieving some form of endoscopic improvement from FMT treatment. Endoscopic remission rate did not vary between FMT and placebo group (12% vs 8%, respectively), but endoscopic response was three times higher in the FMT group (32% vs. 10%).
Primary outcome (defined as the study’s goal of achieving both clinical remission and endoscopic remission or response):
- Of patients receiving FMTs, 27% achieved both steroid-free clinical remission and endoscopic remission or response.
Donor specific findings:
Interestingly, one specific donor appeared to be associated with more benefit than other donors. 37% of patients treated with FMT that contained a sample from this donor achieved the primary outcome, compared with 18% of patients who’s FMT did not include a sample from this donor.
Discussion:
It was found in the study that patients with severe inflammation or dependence on steroids had a response to FMT treatment, but were less likely to achieve the primary outcome (clinical remission and endoscopic remission/response). This aligns with my research that it is crucial to reduce inflammation before FMT therapy in order for the new microbiome to take hold. As this study shows, FMT can help reduce that inflammation, but response was greater in patients with less severe disease at the start of treatment. As the paper puts it, “this finding could reflect disease that is resistant to faecal microbiota transplantation treatment, or it could be that prolonged therapy and slower steroid reduction is needed in these patients” (emphasis mine). Furthermore, “these findings… suggest that unlike for C difficile infection, which generally responds to a single infusion, faecal microbiota transplantation treatment for ulcerative colitis needs to be more intense. ”
The study authors also touch on the importance of personalized medicine, and that a one-size fits all approach may not be the best for a disease like UC. “The optimum intensity and duration of faecal microbiota transplantation in ulcerative colitis remains to be defined. In our study, patients varied in their time to achieve clinical remission… The duration and intensity of faecal microbiota transplantation therapy might need to be individualised: treatment once a week could be effective in some patients, whereas more intensive therapy might be needed in others.”
This study was a new landmark for showing the efficacy of FMT for treating Ulcerative Colitis. This study shows that intensive FMT treatment with multiple donors is a very promising treatment for UC. Further research and studies will be needed to understand specific aspects of the treatment and characterise the biological and microbiological mechanisms at play, but this is a very exciting look into the future of Ulcerative Colitis treatment.
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