A Randomized, Double-Blind Trial of Oral Fecal Microbiota Transplantation Capsules Compared to Placebo in Adults with Active Ulcerative Colitis

What this Trial Is About

Researchers are evaluating fecal microbiota transplantation FMT for patients with active ulcerative colitis UC in this multi-centre, randomized, double-blind, placebo-controlled feasibility trial. The goal is to see if a larger full-scale study comparing FMT to placebo in an expanded UC population is possible and practical. Participants will include adults with active UC, recruited from three Canadian healthcare centers. Participants will be assigned to one of two groups either to add FMT capsules to their current therapy or to start or switch to a new advanced medication alongside FMT. The treatment involves oral lyophilized fecal microbiota transplantation LFMT capsules or placebo capsules that look identical. The dosing includes an induction phase with higher capsule counts followed by a maintenance phase over several weeks. Throughout the study, participants will take capsules daily for up to 24 weeks, beginning with an induction phase of 1 week at 4 capsules per day, then 1 week at 2 capsules per day, followed by 6 weeks at 1 capsule daily, and then a maintenance phase of 16 weeks with 1 capsule daily. Researchers will assess steroid-free endoscopic remission at 8 weeks as the primary outcome. Secondary measures include monitoring adverse events and quality of life assessments at various points. Safety and treatment effects will be closely followed during and after treatment.

Fecal Microbiota Transplantation in an Expanded Ulcerative Colitis Population