NCT05202990Not yet recruitingPhase 2
Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis
Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis.
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 26 (estimated)
- First submitted
- 10 Jan 2022
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Ulcerative colitis
- NCT number
- NCT05202990
- EU CT number
- 2024-518044-20-00
- EudraCT number
- 2020-000311-71
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 26
- From 1 Jul 2026 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other
- 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
Who the study is looking for
- 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
Age in the registry: 8 years to 17 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.