This trial is active, not recruiting.

Conditions primary sclerosing cholangitis, biliary atresia
Treatment vancomycin
Phase phase 1
Sponsor Stanford University
Start date May 2007
End date October 2011
Trial size 21 participants
Trial identifier NCT01322386, 4751


The goals of the proposed work are two fold:

Firstly, to see if the antibiotic vancomycin may be used for the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC). The investigators hope to learn what effect Vancomycin has on the bacteria that are present in stool, body fluid or intestinal tissue on someone who has BA and PSC and if so by what mechanism. Secondly, the investigators hope to learn to characterize human intestinal microbial communities (microbiome: the collection or collectivity of microorganisms) using molecular methods, examine the mechanisms of interaction between host and microbiome using genomic approaches, and determine how the microbiome both preserves local health and promotes pathology. The investigators will focus on primary sclerosing cholangitis, biliary atresia, as well as states of health. The composition of the associated microbiome will be assessed based on ribosomal DNA and RNA sequences, and attention will be given to richness (diversity), evenness (relative abundance), and variation with respect to time, person, and anatomic niche. Host response at the adjacent mucosal surface will be assessed based on genome-wide gene expression patterns.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
vancomycin Vancocin
Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months.

Primary Outcomes

Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia
time frame: Within 3 months of therapy

Eligibility Criteria

Male or female participants from 1 month up to 20 years old.

Inclusion Criteria: - Clinical diagnosis of biliary atresia or primary sclerosing cholangitis. - Clinical controls who are undergoing upper endoscopy or colonoscopy and do not have biliary atresia or primary sclerosing cholangitis. - Subjects who have been on oral vancomycin for 1 year for biliary atresia or - Exclusion Criteria: - Patients that have taken antibiotics within the last 3 month will be excluded as this will alter the original bacterial flora.

Additional Information

Official title The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin.
Principal investigator Kenneth L Cox, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by Stanford University.