XXX (1) - Fecal Microbiota Transplantation (FMT) & Ulcerative Colitis (UC)

Study overview:

It is a pilot study to evaluate Fecal Microbiota Transplantation (FMT) or placebo in 61 randomized patients with Ulcerative Colitis (UC) in clinical remission. The standard of care [SOC] therapy was continued in all patients (1).

Primary outcome measures:

Endpoint was maintenance of steroid-free clinical remission [Mayo score ≤2, all subscores ≤1] at Week 48 (1).

Results:

The main goal was met by 27 out of 31 patients (87.1%) who received FMT, compared to 20 out of 30 patients (66.7%) who received the placebo. This difference was not statistically significant (p = 0.111). However, more patients who received FMT achieved secondary goals, such as endoscopic remission (18 out of 31, or 58.1%, compared to 8 out of 30, or 26.7%, for placebo, p = 0.026) and histological remission (14 out of 31, or 45.2%, compared to 5 out of 30, or 16.7%, for placebo, p = 0.033). Relapse occurred in 3 patients (9.7%) who received FMT and in 8 patients (26.7%) who received the placebo (1).

Conclusion:

The primary endpoint was not reached. However, maintaining FMT in patients who are in clinical remission may help sustain clinical, endoscopic, and histological remission in patients with UC (1).

References:

(1) Sood et al. 2019 J Crohns Colitis. 13: 1311-7