Inflammatory Bowel Disease Clinical Trial
Official title:
A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis
Verified date | July 2020 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | December 1, 2018 |
Est. primary completion date | May 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Microbiome diversity analysis | Fecal samples collected over the course of a week will be assessed by 16S r-Ribosomal Ribonucleic Acid gene profiling. Intestinal microbial communities will be assessed pre and post vancomycin administration. | 5 days |
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