Plain-English translation of NCT05327790 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Ulcerative Colitis research guide →Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing whether adding lyophilized fecal microbiota transplantation (LFMT)—capsules containing beneficial bacteria from healthy donor stool—can help improve results when started alongside vedolizumab or ustekinumab, two biologic medications used to treat ulcerative colitis. Half of the participants will receive the real treatment, and half will receive placebo capsules that look identical but contain only inactive ingredients. The goal is to see if the medication works better when combined with this bacterial treatment.
Ulcerative colitis is caused by inflammation in the colon, and while biologic medications help many patients, some people don't respond well enough or continue to have active disease. Researchers believe that restoring healthy gut bacteria might work together with the medication to reduce inflammation more effectively and help more people get better.
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If you join this study, you will start taking capsules on day 0 during a clinic visit at either the University of Alberta or University of Manitoba, where you'll take an initial dose of 15 capsules under observation. After that, you'll take 5 capsules daily at home for 8 weeks while also starting your new biologic medication as prescribed. Throughout the study, you'll have follow-up visits to check how you're doing and whether your symptoms improve.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
Canada
Phase
Testing effectiveness
Sponsor
University of Alberta
Enrollment target
~40 participants
Started
June 2022
Primary completion
March 2027
Age range
18 Years – 75 Years
Last updated on clinicaltrials.gov in May 2026.
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