ACTRN12619000611123 - Fecal Microbiota Transplantation (FMT) & Ulcerative Colitis (UC)

Background:

Fecal Microbiota Transplantation (FMT), either through a colonoscopy or an enema, can help some people with active ulcerative colitis feel better. However, we don't know if taking these healthy bacteria by mouth works for ulcerative colitis (1).

Study overview:

It is a double-blind, randomized, placebo-controlled treatment trial to evaluate Fecal Microbiota Transplantation (FMT) (capsules containing freeze-dried fecal microbiota transplant (FMT) or placebo in 35 patients (aged 18 to 75) with active ulcerative colitis (1).

Primary outcome measures:

Corticosteroid-free clinical remission with endoscopic remission or response (total Mayo score ≤2, all subscores ≤1, and ≥1 point reduction in endoscopic subscore) at week 8. At week 8, FMT responders were randomly assigned (in a 1:1 ratio, permuted block size of 8) to either continue or withdraw FMT for a further 48 weeks (1).

Results:

After 8 weeks, 8 out of 15 patients who got FMT were doing well without needing corticosteroids, and their condition improved when checked with a scope. In the placebo group, only 3 out of 20 patients showed similar improvement. This means there was a 38.3% difference between the two groups, and the chance of this happening by luck was low (p=0.027). The odds of improvement were 5 times higher for the FMT group (1).

After the initial phase, 10 patients from the FMT group who showed improvement moved to the next phase. They were split into two groups: 4 continued with FMT, and 6 stopped the treatment. By week 56, all 4 patients who kept getting FMT were in full remission, meaning their symptoms, scope results, and tissue samples were all normal. None of the patients who stopped FMT had the same results (1).

Conclusion:

Taking antibiotics and then using fecal microbiota transplantation by mouth helped patients with active ulcerative colitis go into remission. Keeping up with FMT was easy for patients to handle and seemed to work well in improving symptoms, as seen in medical tests and tissue samples. Using oral FMT might be a good and practical treatment choice for people with ulcerative colitis (1).

References:

(1) Haifer et al. 2022 The Lancet Gastroenterology & Hepatology 7(2): 141-151