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NOT YET RECRUITING
NCT05202990
PHASE2

Oral Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Official title: Pilot Study of a New Technique of Oral Fecal Transplantation Using Frozen Stool Capsules for the Maintenance Treatment of Pediatric Ulcerative Colitis.

Key Details

Gender

All

Age Range

8 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2025-07-01

Completion Date

2027-10-01

Last Updated

2025-04-17

Healthy Volunteers

Yes

Interventions

DRUG

Fecal Microbiota Transplantation by Stool capsules

After colon cleansing using PolyEthylen glycol, the patient will have a colonoscopy under general anaesthesia. The patient will then receive orally FMT (frozen stools capsules prepared from healthy donor feces).

DRUG

Fecal Microbiota Transplantation by Intra-rectal enemas

After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anaesthesia. The patient will then receive first FMT (frozen preparation of stools) by infusion in caecum during colonoscopy and the second and third doses by enemas.

Locations (3)

Department of gastroenterology, Armand Trousseau Hospital

Paris, France

Department of Pediatric Gastroenterology, Hepatology and Nutrition - Necker - Enfants Malades Hospital

Paris, France

Department of Pediatric Gastroenterology, Robert Debré Hospital

Paris, France