Active — Not RecruitingNot Applicable

Efficacy and Mechanism of FMT in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study

China94 participantsStarted 2025-08-01

Plain-language summary

This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence. * IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases. * Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449) * Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved. * Voluntary participation and signing of informed consent. * Adults aged 18-65. * Can tolerate oral enterobacteria transplantation capsule treatment. Exclusion Criteria: * The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence. * IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases. * Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449) * Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved. * Voluntary participation and signing of informed consent. * Adults aged 18-65. * Can tolerate oral enterobacteria transplantation capsule treatment.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Endoscopic remission rate

Timeframe: 14th and 52nd week after joining the group.

Clinical remission rate

Timeframe: 14th and 52nd week after joining the group.

Trial details

NCT IDNCT07149441

SponsorShanghai 10th People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

View on ClinicalTrials.gov More Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis) trials