Plain-English translation of NCT05321758 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Read our Crohn Disease research guide →This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing whether (FMT)—a procedure where healthy bacteria from a donor's stool are transferred into a patient's digestive system—can treat active Crohn's disease in children when combined with a special high-nutrition liquid diet. Researchers believe that Crohn's disease develops partly because of an imbalance in gut bacteria and an overactive immune response, so this treatment aims to restore healthy bacteria while giving the gut a chance to heal. The study will compare this new approach against the standard current treatment, which uses immunosuppressant medications.
Current treatments for childhood Crohn's disease rely heavily on medications that suppress the immune system, which can have significant side effects. This trial exists to see whether restoring a healthy gut microbiome might be a gentler, first-line option that could help children achieve remission without those risks.
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You would be randomly assigned to one of two groups: the new treatment group (receiving gut bacteria transplants plus a specialized liquid diet) or the standard treatment group (receiving the same liquid diet plus immunosuppressant medications). If you're in the transplant group, you would receive 1 to 3 courses of , with 3 to 6 transplants per course, delivered by capsule, enema, or colonoscopy. Both groups would follow the special high-nutrition liquid diet for 80% of daily calories. You would also need regular colonoscopies to monitor how well the treatment is working and check for healing in your digestive tract.
AI-generated summary from trial data · Jul 20, 2026 · Not medical advice
China
Sponsor
Tongji Hospital
Enrollment target
~50 participants
Started
March 2020
Primary completion
June 2027
Age range
2 Years – 16 Years
Last updated on clinicaltrials.gov in July 2026.
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Central contact
Biao Zou, MD
Tongji Hospital
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.