Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
This trial is active, not recruiting.
|Conditions||primary sclerosing cholangitis, biliary atresia|
|Start date||May 2007|
|End date||October 2011|
|Trial size||21 participants|
|Trial identifier||NCT01322386, 4751|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia
time frame: Within 3 months of therapy
Male or female participants from 1 month up to 20 years old.
- 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 -
- Patients that have taken antibiotics within the last 3 month will be excluded as this will alter the original bacterial flora.
|Official title||The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin.|
|Principal investigator||Kenneth L Cox, MD|
Call for more information