Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Stanford University
• Treatments: Anti-Infective Agents; Vancomycin

Criteria

Inclusion Criteria:

• PSC Diagnosis: Liver biopsy and/or imaging (MRCP, ERCP, CT, or US

• Colonoscopy within 1 year or starting of study

• 2 groups:

1. IBD (Inflammatory bowel disease) and PSC: details of extent and type of IBD

2. No IBD and PSC, but positive p-ANCA or ASCA serologies indicating possible IBD.

Exclusion Criteria:

• Allergy to Vancomycin

• PSC not associated with IBD or NO positive IBD antibodies (p-ANCA [anti- neutrophil cytoplasmic antibody] or ASCA [anti-Saccharomyces cerevisiae antibody])

• Cholangiocarcinoma

• On oral or topical (enemas or suppositories) corticosteroids,topical mesalamine, or biologics (infliximab, adalimumab, certolizumab).