Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01322386
• Date of registration: 10/02/2011
• Prospective Registration: No
• Primary sponsor: Stanford University
• Public title: Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin PSC
• Scientific title: The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin.
• Date of first enrolment: May 2007
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01322386
• Study type: Interventional
• Phase: Phase 1

Contacts

• Name: Kenneth L Cox, MD
• Affiliation: Stanford University

Key inclusion & exclusion 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.



Age minimum: 1 Month
Age maximum: 20 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sclerosing Cholangitis

Biliary Atresia

Intervention(s)

Drug: Vancomycin

Primary Outcome(s)

Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia [Time Frame: Within 3 months of therapy]

Secondary ID(s)

4751

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 04/03/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01322386