A Phase 1 interventional study of Oral Vancomycin in Primary Sclerosing Cholangitis and Biliary Atresia, sponsored by Sacramento Pediatric Gastroenterology. Recruiting at 1 site in United States. Open to participants aged 2 Weeks to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-15.
Sponsored by Sacramento Pediatric Gastroenterology · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
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
Also known as: ANI
Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia
Blood tests, imaging studies and/or liver biopsy changes before and while on oral vancomycin will determine the benefit of the treatment.
Time frame: 3 months
Plan to share: Yes — Data collected throughout study and will be shared via publications when available at certain time points.
No publications or documents are linked to this record.
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