A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02464020
• Date of registration: 29/05/2015
• Prospective Registration: Yes
• Primary sponsor: University of Minnesota
• Public title: A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis
• Scientific title: A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis
• Date of first enrolment: July 2015
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02464020
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Byron P Vaughn, MD
• Affiliation: University of Minnesota

Key inclusion & exclusion criteria

Inclusion Criteria:

- Documented diagnosis of PSC made by typical clinical, radiographic and biochemical
criteria.

- Diagnosis of PSC > 3 months

Exclusion Criteria:

- Antibiotic use within 30 days of initial study visit

- Probiotic use within 30 days of initial study visit

- Extensive ileal disease

- Severe of fulminant IBD

- Diabetes and/or metabolic syndrome

- Chronic disease state deemed unacceptable for the study per investigator review

- Decompensated Cirrhosis

- Females who are pregnant or breastfeeding



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Inflammatory Bowel Disease

Primary Sclerosing Cholangitis

Intervention(s)

Drug: Vancomycin

Primary Outcome(s)

Fecal bile acid composition [Time Frame: 5 days]

Secondary Outcome(s)

Microbiome diversity analysis [Time Frame: 5 days]

Secondary ID(s)

GI-2015-23049

Source(s) of Monetary Support

Please refer to primary and secondary sponsors