At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of large-duct PSC based on cholangiogram
- ✓Age 15-70 years
- ✓Baseline ALP ≥1.5 times upper limit normal
- ✓No biliary obstruction or malignancy within 6-12 months prior to study entry
- ✕Antibiotic or probiotic use within 3 months prior to study
- ✕Expected to receive antibiotics in weeks leading to enrollment
- ✕Allergy to vancomycin or teicoplanin
- ✕Biliary intervention within 3 months prior or planned
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT05876182Phase 2RecruitingMonitorUpdated 11mo ago · Completion was 1mo agoA Prospective, Randomized, Placebo-controlled Clinical Trial of Oral Vancomycin in Adults and Young Adults (15-17 Years Old) Affected by Primary Sclerosing Cholangitis With or Without Inflammatory Bowel Disease
In Brief
A Phase 2 clinical trial evaluating Oral Vancomycin and Placebo for Primary Sclerosing Cholangitis and 2 related conditions. Currently recruiting, targeting 84 participants across 1 site.
Signals
Detailed Summary
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.
Study Details
Timeline
Interventions
The investigator will identify potential participants and confirm the diagnosis of PSC. Subjects will be screened within 10 weeks before randomization to determine the eligibility. Study participants will be consecutively randomized to oral vancomycin or placebo and investigational drug and placebo dispensed.
The investigator will identify potential participants and confirm the diagnosis of PSC. Subjects will be screened within 10 weeks before randomization to determine the eligibility. Study participants will be consecutively randomized to oral vancomycin or placebo and investigational drug and placebo dispensed.