Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal

PHASE3RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

September 22, 2021

Primary Completion Date

May 22, 2027

Study Completion Date

July 22, 2029

Conditions
Crohn Disease
Interventions
DRUG

Fecal Microbiota Transplantation (FMT)

"The colonoscopy for FMT will be planned between 7 and 14 days after the last adalimumab or sub-cutaneous infliximab administration and 6 weeks +/- 7 days after the last intravenous infliximab administration 14 and 28 days following the last sub-cutaneous golimumab administration. After colon cleansing using polyethylene 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 saline (NaCl 0.9%), (FMT vehicle in the terminal ileum or the colon.~At W12 and W24 after first colonoscopy, the patient receives treatment by capsule (15 capsules contain 0.8g of stools by visit)."

DRUG

Sham-transplantation (placebo)

"The colonoscopy for sham-transplantation will be planned between 7 and 14 days after the last adalimumab or sub-cutaneous infliximab administration and 6 weeks +/- 7 days after the last intravenous infliximab administration, 14 and 28 days following the last sub-cutaneous golimumab administration. After colon cleansing using polyethylene glycol, the patient will have a colonoscopy under general anesthesia. The patient will then receive either sham transplantation (frozen preparation of NaCl 0.9% with 10% glycerol) in the terminal ileum or the colon.~At S12 and S24 after first colonoscopy, the patient receives treatment by capsule (15 capsules contain placebo)."

Trial Locations (1)

75012

RECRUITING

Gastroenterology Department of Saint Antoine Hospital, 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