Testing Stool Capsules for Children with Ulcerative Colitis in Remission
Tests stool-based capsules, taken by mouth, in children with ulcerative colitis in remission.
Plain-language title generated from the registry record
Registry title: Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis
Key facts
- Where
- Paris, FranceSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 17 years old?
Source: NCT05202990, who can take part
Where in France
- Assistance Publique Hopitaux de ParisParis, FranceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Trial code
- NCT05202990EU 2024-518044-20-00
- Record updated
- 6 May 2026
- Original description
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.Read full original descriptionShow less
Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis.
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.
Inclusion: 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: 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; isolated proctitis (<5 cm); Being on enteral nutrition; Being pregnant or breastfeeding, or have a positive pregnancy test; Have a contraindication to colonoscopy or general anaesthesia.