Impact of Fecal Microbiota Transplantation in Ulcerative Colitis

PHASE3RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 17, 2018

Primary Completion Date

November 17, 2025

Study Completion Date

December 24, 2027

Conditions
Ulcerative Colitis
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."

Trial Locations (1)

75012

RECRUITING

Service de Gastroentérologie et Nutrition Hôpital Saint Antoine, Paris

All Listed Sponsors
collaborator

CRB-HUEP

UNKNOWN

collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT03483246 - Impact of Fecal Microbiota Transplantation in Ulcerative Colitis | Biotech Hunter | Biotech Hunter