NCT01545908 - Fecal Microbiota Transplantation (FMT) & Ulcerative Colitis (UC)

Background:

Ulcerative colitis (UC) presents significant challenges in treatment, as standard therapies do not consistently lead to remission. An alternative method, fecal microbiota transplantation (FMT), has shown promise by inducing remission in a limited number of patients experiencing active Ulcerative Colitis (UC) (1).

Study overview:

It is a placebo-controlled, double-blind, randomized phase II treatment trial (Parallel Assignment) to evaluate Fecal Microbiota Transplantation (FMT) or placebo in 75 randomized patients with active Ulcerative Colitis (UC) without infectious diarrhea (1).

Primary outcome measures:

Remission of UC with colonic mucosa healing defined as Mayo endoscopy score = 0 at 6 weeks

Results:

Seventy patients completed the trial, although three participants from the placebo group and two from the FMT group dropped out. At the 7-week mark, nine patients who received FMT, accounting for 24%, and two patients who received the placebo, making up 5%, were in remission. This represents a statistically significant difference in risk of 17%, with a 95% confidence interval ranging from 2% to 33%. Additionally, the stool samples from patients who received FMT showed greater microbial diversity compared to their baseline levels, in contrast to those from patients who were given the placebo. This difference was statistically significant, with a P-value of 0.02, as determined by the Mann-Whitney U test (1).

Conclusion:

In the study, FMT was found to induce remission in a significantly higher percentage of patients with active UC compared to those who received a placebo. Importantly, there was no difference in the occurrence of adverse events between the two groups. The outcomes seemed to be influenced by factors such as the fecal donor and the timing of UC (1).

References:

(1) Moayyedi et al. 2015 Gastroenterology 149(1): 102-109