Status:
NOT_YET_RECRUITING
Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
MRSU 938 - Research Center of Saint Antoine
Conditions:
Pediatric Ulcerative Colitis in Remission
Eligibility:
All Genders
8-17 years
Phase:
PHASE2
Brief 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 increas...
Detailed Description
Ulcerative colitis (UC) is characterized by chronic inflammation of the colon of undetermined origin. Their incidence is increasing dramatically in the paediatric population. Pediatric-onset inflamma...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05202990
Start Date
July 1 2025
End Date
October 1 2027
Last Update
April 17 2025
Active Locations (3)
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1
Department of gastroenterology, Armand Trousseau Hospital
Paris, France, 75012
2
Department of Pediatric Gastroenterology, Hepatology and Nutrition - Necker - Enfants Malades Hospital
Paris, France, 75015
3
Department of Pediatric Gastroenterology, Robert Debré Hospital
Paris, France, 75019