Study of Oral Fecal Microbial Transplant Capsules to Treat Rheumatoid Arthritis Randomized, Double-Blind, Placebo-Controlled Trial With Standard Rheumatoid Arthritis Care

What this Trial Is About

Researchers are studying the effects of fecal microbial transplant FMT capsules from healthy donors on patients with rheumatoid arthritis RA. This randomized, double-blind, placebo-controlled trial aims to evaluate changes in gut bacteria and intestinal health, as well as RA-associated antibodies, in 30 RA patients who meet specific criteria such as stable therapy and low disease activity. The study is sponsored by London Health Sciences Centre Research Institute and Lawson Research Institute of St. Josephs. Participants are randomly assigned to receive either a single dose of 35-40 FMT capsules or placebo capsules, both taken orally with water. The FMT dose totals 80-100 grams and the administration takes about 30 minutes. All participants continue their standard RA care throughout the trial. The study includes four visits baseline, treatment, and follow-ups at 6 and 12 weeks. During these visits, patients will be assessed by rheumatologists, complete surveys, and provide biological samples including stool, urine, and blood. Samples are collected at baseline, 6 weeks, and 12 weeks depending on type. The main outcomes measured include changes in intestinal permeability and RA-related antibodies, as well as any adverse events. Secondary outcomes include changes in gut microbial composition and C-reactive protein levels. The study will conclude by April 2026.

Fecal Microbial Transplantation for Rheumatoid Arthritis Trial