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Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

Information source: Stanford University
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: Vancomycin (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Kenneth L Cox, MD, Principal Investigator, Affiliation: Stanford University

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: 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: 1 Month. Maximum age: 20 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Long-term Treatment of Primary Sclerosing Cholangitis in Children With Oral Vancomycin: An Immunomodulating Antibiotic

Starting date: May 2007
Last updated: March 23, 2011

Page last updated: August 23, 2015

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