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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Treatment of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects

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

Detailed Summary: The purpose of this study is to evaluate changes in the fecal and salivary microbiota during vancomycin treatment of children and adults with Primary Sclerosing Cholangitis (PSC), identify features of the host microbiota that are associated with disease activity and/or response to treatment and further delineate the immunological effects of oral vancomycin treatment of PSC. This study will correlate changes in microbiota with the immunological effects of oral vancomycin in children and adults with PSC. The results of this proposal will lead to new and validated targets for diagnosis and treatment of PSC that will have high impact in the short and long term for patients and their families.
Sponsor: Stanford University

Current Primary Outcome: Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis within 3 months of therapy. [ Time Frame: Within 3 months of therapy ]

Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis. Blood tests(liver enzymes - ALT and GGT), imaging studies (MRI, ERCP) and/or liver biopsy changes before and while on oral vancomycin will assess the benefit of the therapy.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Stanford University

Dates:
Date Received: February 21, 2013
Date Started: January 2012
Date Completion: June 2017
Last Updated: October 12, 2016
Last Verified: October 2016