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