Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: MRSU 938 - Research Center of Saint Antoine

Criteria

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

Inclusion Criteria for healthy volunteers donors:

• Aged between 20 and 50 years

• Body mass index (BMI) between 17 kg / m² and 27 kg / m²

• Usually regular transit defined as at least one stool per day, usually issued in the morning

• For women of childbearing age:

o have a negative pregnancy (or urine) blood test

• Subject with health insurance

• Informed Written consent

Exclusion Criteria for patients:

• isolated proctitis (<5 cm)

• severe colitis defined by a PUCAI score> 65

• 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 Criteria for healthy volunteers donors:

• For details, please see protocol