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 range8 Years – 17 Years
SexALL
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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
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)