Overview

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

Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this study is to assess if oral vancomycin can restore the normal bile acid metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease. Study participants will provide blood and stool samples in order to evaluate the bile acid metabolism before a short course of vancomycin and then again after to assess for change. The investigators will also assess the blood and stool of healthy people, and people with IBD (without PSC) as a control group.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
Treatments:
Bile Acids and Salts
Vancomycin
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