Overview

This trial is active, not recruiting.

Condition primary sclerosing cholangitis
Treatment oral vancomycin
Phase phase 3
Sponsor Stanford University
Start date January 2012
End date June 2017
Trial size 40 participants
Trial identifier NCT01802073, 22591

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
1) For children who weight < or = 30 kg, the vancomycin dose will be 50 mg/kg/day given orally 3 times per day for the 1st month and continue with the same dose for subsequent months if the clinical laboratory studies improved and are normal. If the laboratory studies are not normal the dose will be increased to 75 mg/kg/day given orally 3 times per day for the 2nd month and 100mg/kg/day given orally 3 times per day the 3rd month. If the laboratory studies do not improve by the end of the 3rd month since starting the vancomycin, the vancomycin will be stopped and the child will not continue the study. 2) For adults and children who weigh >30 kg, the vancomycin dose will be 500 mg given orally 3 times per day for the 1st month and continue with this dose if the clinical laboratory studies improve and are normal. If the laboratory studies are not normal the dose will be increased to 750 mg 3 times per day for the 2nd month and 1000 mg 3 times per day the 3rd month.
oral vancomycin Vancocin

Primary Outcomes

Measure
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis within 3 months of therapy.
time frame: Within 3 months of therapy

Eligibility Criteria

Male or female participants at least 1 year old.

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).

Additional Information

Official title Treatment of Primary Sclerosing Cholangitis in Inflammatory Bowel Disease Patients With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Principal investigator Kenneth Cox, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Stanford University.