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NOT YET RECRUITING
NCT07477782
PHASE2

Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT) on ALP and bilirubin compared to sham transplantation in addition to ursodeoxycholic acid (UDCA) treatment in PSC patients.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-05

Completion Date

2030-05

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

DRUG

Fecal microbiota transplantation (FMT)

One to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy. The patient will then receive either FMT (suspension of 50g of stools in 300ml of cryopreservative solution) in the terminal ileum or the caecum. At W12 and W24 after first colonoscopy , the patient will receive orally 20 FMT (capsules swallowed in front of a physician or a nurse in hospital)

DRUG

Sham-transplantation (placebo)

One to 4 weeks after randomization, the patient will be hospitalized in one of the hepato-gastroenterology department involved in the study for the colonoscopy. The patient will then receive sham transplantation (FMT vehicle, i.e. 300ml of cryopreservative solution) in the terminal ileum or the caecum. At W12 and W24 after first colonoscopy , the patient will receive orally 20 sham capsules (capsules swallowed in front of a physician or a nurse in hospital)

Locations (1)

Hepatology Department, Saint Antoine Hospital

Paris, France