Trial | NCT02137668  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Intervention/Treatment

    vancomycin ...

  • Study Participants

    200
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.
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.
Study Started
Jul 31
2010
Primary Completion
May 31
2018
Anticipated
Study Completion
Jul 31
2028
Anticipated
Last Update
Nov 15
2016
Estimate

Drug Oral Vancomycin

Oral Vancomycin is given to PSC or BA participants

  • Other names: ANI

Oral Vancomycin Experimental

Every participant with PSC or BA will received the same Arm of Oral Vancomycin

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.
No Results Posted