Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sha… (NCT07477782) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation
France72 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Males or females
* Age ≥18 and ≤75 years
* Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and /or extrahepatic biliary duct changes consistent with PSC
* IBD diagnosed according to international guidelines (presence of endoscopic and histologic signs)
* IBD inactive for at least 6 months (defined by no evidence of flare and no change in treatment)
* ALP ≥ 1.3 ULN (at least 2 times within a 3 months pre-inclusion period) or elevated total bilirubin ≤50 umol/l (with concomitant elevated direct bilirubin).
* Treatment with UDCA (13-23 mg/kg/d) for at least 6 months and at the same dosage for at least 3 months
* Using contraceptive in women of childbearing potential and agrees to pursue it from inclusion until week 48. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used constantly and correctly.
* Written informed consent signed
* Subject affiliated to the French
* Social Security System
Exclusion Criteria:
* Small duct PSC
* Autoimmune hepatitis defined by the presence of moderate to severe interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: AST or ALT \> 5 ULN, Positive anti smooth muscle auto antibodies or serum…
What they're measuring
1
To assess in patients with PSC the efficacy of FMT versus sham transplantation on ALP and bilirubin at week 48 addition to standard UDCA therapy.