NCT02137668

Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Sacramento Pediatric Gastroenterology · Academic / Other
• Sex: All
• Age: 2 Weeks – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Investigation 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. In addition, changes in the metabolites of the blood will be analyzed. To see if the antibiotic vancomycin, when used for the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC) is effective treatment for these diseases. 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.

Conditions

• Primary Sclerosing Cholangitis
• Biliary Atresia

Interventions

Type	Name	Description
DRUG	Oral Vancomycin	Oral Vancomycin is given to PSC or BA participants

Timeline

• Start date: 2010-07-01
• Primary completion: 2018-05-01
• Completion: 2028-07-01
• First posted: 2014-05-14
• Last updated: 2016-11-15

Locations

1 site across 1 country: United States