NCT05876182
Vancomycin in Primary Sclerosing Cholangitis in Italy
Recruiting · Phase 2 · University of Milano Bicocca · registry updated 2025-07-25
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications. This is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg/day) in subject between 15 - 70 years old with PSC.
Inclusion
- Willing and able to give informed consent prior to any study specific procedure being performed;
- Male and non-pregnant, non-lactating female subjects, including women of child bearing potential (WOCBP), between 15-70 years of age at the time of informed consent;
- Diagnosis of large-duct PSC based on cholangiogram (at MRCP, ERCP, PTC) according to the most recent published guidelines (EASL);
- Baseline ALP ≥1.5 times upper limit normal at screening;
- Absence of biliary obstruction and/or malignancy within 6-12 months of entry into the study;
- If a patient is on ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid he or she is expected to remain on the same daily dose during the study period;
Exclusion
- Receiving an antibiotic or probiotic within 3 months prior to the study;
- Expected to receive antibiotics within the weeks leading up to enrollment (such as patients with recurrent cholangitis, ongoing infectious illnesses, etc.);
- Allergy to vancomycin or teicoplanin;
- Biliary intervention within 3 months prior to study enrollment or planned;
- Alcohol abuse (defined as greater than 14 standard drinks units per week in men; greater than 7 standard drinks units per week);
- Pregnancy and lactation;