A Phase 1 interventional study of Vancomycin in Primary Sclerosing Cholangitis and Inflammatory Bowel Disease, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-17.
Sponsored by University of Minnesota · Phase 1, Interventional, and Basic science
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.
Primary Sclerosing Cholangitis (PSC) is a chronic inflammatory and fibrotic disease of the intra and extrahepatic ducts of unknown etiology that predominately occurs in people with Inflammatory Bowel Disease (IBD). One hypothesis is that altered microbiome (bacteria in the gut) in people with IBD are responsible for the inflammation in the liver seen in PSC. Bile acids (BAs) represent a unique mechanism of communication between the host and intestinal microbiome and the liver. Synthesized in the liver, bile acids are metabolized by intestinal bacteria hydroxylases to secondary BAs which then re-enter the portal circulation. Altered metabolism of BAs has been associated with gallstones and colorectal cancer and is hypothesized to play a role in the inflammatory response of certain disease such as IBD and PSC.
IBD has been associated with impairment of bile acid (BA) metabolism. In addition BAs play a role in regulating bacterial growth of the intestine and thus have an effect on the integrity of the intestinal mucosa, which is an essential component of IBD. Perturbations in this system could increase bacterial translocation into the portal system due to loss of protective mucosal factors or bacterial overgrowth.
The overall goal of this study is to assess the changes in BAs metabolism following administration of oral vancomycin. The investigators will also describe the relationship of the intestinal microbiome and BA metabolism in PSC/IBD.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's enrollment of 8 is below the median of 70 across 770 interventional studies indexed under Inflammatory Bowel Diseases.
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Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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Exclusion Criteria:
Two week course of oral vancomycin 500mg twice a day.
Drug: Vancomycin
A control group of participants without Primary Sclerosing Cholangitis. Control group will consist of both healthy subjects and subjects with Inflammatory Bowel Disease.
Oral vancomycin: 500mg suspended in prefilled syringes for oral use
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
Time frame: 5 days
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.
Time frame: 5 days
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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University of Minnesota