Phase 1
N=21
Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
Primary Sclerosing Cholangitis · Biliary Atresia
Bottom Line
View on ClinicalTrials.gov: NCT01322386 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Mar 2016
Primary outcome: Primary: Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia — 10; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Vancomycin (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia |
10; 0; 0; 0; 0; 9 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 -
Exclusion Criteria
- Patients that have taken antibiotics within the last 3 month will be excluded as this will alter the original bacterial flora.
Data sourced from ClinicalTrials.gov (NCT01322386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.