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

Completed · Phase 1

Conditions studied: Primary Sclerosing Cholangitis, Inflammatory Bowel Disease

In brief

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.

Key facts

Study ID

NCT02464020

Run by

University of Minnesota

People needed

8

Starts

2015-07-01

Expected to finish

2018-12-01

Last updated by the study team

2020-07-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented diagnosis of PSC made by typical clinical, radiographic and biochemical criteria.
• Diagnosis of PSC > 3 months

You may not qualify if…

• 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

Where it is running

• University of Minnesota Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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