Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
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|ClinicalTrials.gov Identifier: NCT02137668|
Recruitment Status : Recruiting
First Posted : May 14, 2014
Last Update Posted : November 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Primary Sclerosing Cholangitis Biliary Atresia||Drug: Oral Vancomycin||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||July 2028|
Experimental: Oral Vancomycin
Every participant with PSC or BA will received the same Arm of Oral Vancomycin
Drug: Oral Vancomycin
Oral Vancomycin is given to PSC or BA participants
Other Name: ANI
- Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia [ Time Frame: 3 months ]Blood tests, imaging studies and/or liver biopsy changes before and while on oral vancomycin will determine the benefit of the treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137668
|United States, California|
|Sacramento Pediatric Gastroenterology||Recruiting|
|Sacramento, California, United States, 95841|
|Contact: Yinka Davies, MD 916-332-1244|
|Principal Investigator: Yinka Davies, M.D.|
|Principal Investigator:||Yinka Davies, M.D.||Sacramento Pediatric Gastroenterology|