Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2016
• Main ID: NCT02137668
• Date of registration: 12/05/2014
• Prospective Registration: No
• Primary sponsor: Sacramento Pediatric Gastroenterology
• Public title: Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
• Scientific title: The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
• Date of first enrolment: July 2010
• Target sample size: 200
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02137668
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Yinka Davies, MD

• Name: Yinka Davies, M.D.
• Affiliation: Sacramento Pediatric Gastroenterology

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 40 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Biliary Atresia

Primary Sclerosing Cholangitis

Intervention(s)

Drug: Oral Vancomycin

Primary Outcome(s)

Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia [Time Frame: 3 months]

Secondary ID(s)

Davies 1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors