A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis
1 other identifier
interventional
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2015
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 17, 2020
July 1, 2020
1.8 years
May 29, 2015
July 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Fecal bile acid composition
Fecal samples will be collected over 1 week. Bile acids will be measured on each sample and the average composition of primary to secondary bile acids over the 5 day period will be assessed. Comparison will be made pre and post vancomycin
5 days
Secondary Outcomes (1)
Microbiome diversity analysis
5 days
Study Arms (2)
primary sclerosing cholangitis
EXPERIMENTALTwo week course of oral vancomycin 500mg twice a day.
Control group
NO INTERVENTIONA control group of participants without Primary Sclerosing Cholangitis. Control group will consist of both healthy subjects and subjects with Inflammatory Bowel Disease.
Interventions
Oral vancomycin: 500mg suspended in prefilled syringes for oral use
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Byron P Vaughn, MD
University of Minnesota
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 8, 2015
Study Start
July 1, 2015
Primary Completion
May 1, 2017
Study Completion
December 1, 2018
Last Updated
July 17, 2020
Record last verified: 2020-07