Plain-English translation of NCT04997733 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Crohn Disease research guide →Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing —a procedure where healthy gut bacteria from a donor are transferred into your digestive system—as a way to help people with Crohn's disease maintain remission without needing ongoing anti-TNF medication. Crohn's disease involves an imbalance in gut bacteria and an overactive immune response; the idea is that healthy bacteria from a donor might help restore balance and allow you to stay well. Half of participants will receive the real transplant, and half will receive a sham (fake) transplant, so researchers can see if the treatment truly works.
Current Crohn's disease medications are expensive and can cause serious side effects, so doctors need safer alternatives—especially for patients whose disease is already under control. Early research suggests that transplanting healthy gut bacteria might help some people stay in remission without medication, but larger, rigorous studies are needed to prove this works.
You likely qualify if…
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If you qualify and enroll, you will be randomly assigned to either receive the actual gut bacteria transplant or a sham transplant. You will receive your transplant three times (through colonoscopy and oral administration) and will need to stop taking your anti-TNF medication. The study will follow you for approximately one year, with regular clinic visits and assessments to check whether your Crohn's disease remains in remission and to monitor the health of your gut bacteria. Researchers will use blood tests, stool samples, and colonoscopy to track your progress.
AI-generated summary from trial data · Jun 11, 2026 · Not medical advice
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