NCT01896635 - FOCUS - Fecal Microbiota Transplantation (FMT) (Infusion) & Ulcerative Colitis (UC)

Background:

Concerning NCT01896635 - FOCUS - Fecal Microbiota Transplantation (FMT) (Infusion) & Ulcerative Colitis (UC), the gut microbiota plays a role in the development of ulcerative colitis. Fecal microbiota transplantation is an innovative method of therapeutic microbial manipulation; however, its effectiveness in treating ulcerative colitis remains uncertain (1)

Study overview:

It is a multicentre, double-blind, randomized, placebo-controlled treatment trial (parallel assignment) evaluating Fecal Microbiota Transplantation (FMT) (colonoscopic infusion) or placebo in 85 (enrolled) patients with active ulcerative colitis (Mayo score 4–10) (1)

Primary outcome measures:

Composite Clinical remission & Endoscopic remission / response as measured by Mayo subscores

Results:

In a study, 11 out of 41 patients (27%) who received fecal microbiota transplantation achieved the primary outcome, compared to 3 out of 40 patients (8%) who were given a placebo. The risk ratio was 3.6, with a 95% confidence interval of 1.1 to 11.9, and the p-value was 0.021 (1)

Conclusions:

Intensive-dosing, multidonor fecal microbiota transplantation has been shown to induce clinical remission and endoscopic improvement in cases of active ulcerative colitis. This treatment is linked to specific microbial changes that correlate with the outcomes. As a result, fecal microbiota transplantation emerges as a promising new therapeutic option for managing ulcerative colitis. Moving forward, research should aim to accurately determine the optimal treatment intensity and explore the significance of donor–recipient matching based on microbial profiles (1)

References:

(1) Paramsothy et al. 2017 The Lancet 389: 1218-1228