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Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Information source: Sacramento Pediatric Gastroenterology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Sclerosing Cholangitis; Biliary Atresia

Intervention: Oral Vancomycin (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Sacramento Pediatric Gastroenterology

Official(s) and/or principal investigator(s):
Yinka Davies, M.D., Principal Investigator, Affiliation: Sacramento Pediatric Gastroenterology


The purpose of this study is twofold. First, is to determine whether vancomycin is effective in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and if so, by what mechanism. Secondly, to characterize human intestinal microbial communities and their interactions with the host.

Clinical Details

Official title: The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia


Minimum age: N/A. Maximum age: 40 Years. Gender(s): Both.


Inclusion Criteria:

- Persons who have primary sclerosing cholangitis, biliary atresia, a chronic

intestinal disorder or who are undergoing upper or lower endoscopy.

- Persons who have primary sclerosing cholangitis or biliary atresia who are good

candidates for vancomycin therapy. Exclusion Criteria:

- Patients that have taken antibiotics and/or immunomodulators within the last 3 months

will be excluded as this will alter the original bacterial flora.

- Females who are pregnant may not participate.

Locations and Contacts

Sacramento Pediatric Gastroenterology, Sacramento, California 95841, United States; Recruiting
Yinka Davies, MD, Phone: 916-332-1244
Yinka Davies, M.D., Principal Investigator
Additional Information

Starting date: July 2010
Last updated: November 26, 2014

Page last updated: August 23, 2015

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