Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03483246
PHASE3

Impact of Fecal Microbiota Transplantation in Ulcerative Colitis

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. UC pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts. The purpose of this study is to determine the effect of the fecal microbiota transplantation on UC.

Official title: Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2018-09-17

Completion Date

2027-03-27

Last Updated

2026-01-15

Healthy Volunteers

Yes

Interventions

DRUG

Fecal Microbiota Transplantation (FMT)

The colonoscopy for FMT will be planned as soon as possible and never more than 5 weeks after inclusion visit. After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia. The patient will then receive either FMT (frozen preparation of 50g of stools in 300ml of physio, see donor section for details) or sham transplantation (FMT vehicle) in the cecum.

DRUG

Sham-transplantation Placebo

The sham-transplantation will be planned as soon as possible and never more than 5 weeks after inclusion visit. After colon cleansing using Polyethylen glycol, the patient will have a colonoscopy under general anesthesia. The patient will then sham transplantation (FMT vehicle) in the cecum.

Locations (1)

Service de Gastroentérologie et Nutrition Hôpital Saint Antoine

Paris, Paris, France