NCT01802073

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

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

Detailed description

The purpose of this study is to evaluate changes in the fecal and salivary/urinary 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. Interim results were published in Abarbanel et al, J Clin Immunol 2013 (see References).

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	Oral Vancomycin

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2013-03-01
• Last updated: 2018-09-21
• Results posted: 2018-09-21

Locations

1 site across 1 country: United States