Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis
France26 participantsStarted 2026-07-01
Plain-language summary
The purpose of this study is to evaluate whether FMT by frozen stool capsules in pediatric UC patients in remission after corticosteroid treatment, can modify their dysbiotic gut microbiota by increasing the richness of their microbiota at 6 months.
Who can participate
Age range
8 Years – 17 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 for patients:
* Patient aged 8 to 17 years old
* Ulcerative colitis (UC), whatever the extent, except isolated proctitis (\<5 cm), diagnosed for more than 3 months according to the usual clinical, biological and endoscopic criteria
* Moderate active UC defined by a PUCAI score \> 35 and responding to corticosteroid treatment with a PUCAI score \<10 at enrollment
* Treatment of UC (5-ASA, immunosuppressants, biotherapies) stable for more than 3 months
* Patient able to swallow test capsules
* For girls of childbearing age:
* To have a negative blood (or urine) pregnancy test
* To agree to use a reliable contraceptive method from visit 1 until the end of the research
* Patient with health insurance
* Informed written consent form signed by both parents or by the person (s) with parental authority
Exclusion Criteria for patients:
* isolated proctitis (\<5 cm)
* Being on enteral nutrition
* Have received antibiotic or antifungal treatment in the 4 weeks prior to enrollment
* Having a Clostridioides difficile infection in the 4 weeks prior to enrollment;
* Being pregnant or breastfeeding, or have a positive pregnancy test;
* Have a contraindication to colonoscopy or general anaesthesia
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
1
Success of FMT with frozen stool capsules defined by an increase in the richness of the recipient's microbiota at 6 months.
Timeframe: 6 months after the first Fecal Microbiota Transplantation (FMT)