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