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

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ClinicalTrials.gov Identifier: NCT02464020
Recruitment Status : Active, not recruiting
First Posted : June 8, 2015
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Inflammatory Bowel Disease Drug: Vancomycin Phase 4

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis
Study Start Date : July 2015
Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Arms and Interventions

Arm Intervention/treatment
Experimental: primary sclerosing cholangitis
Two week course of oral vancomycin 500mg twice a day.
Drug: Vancomycin
Oral vancomycin: 500mg suspended in prefilled syringes for oral use
No Intervention: Control group
A control group of participants without Primary Sclerosing Cholangitis. Control group will consist of both healthy subjects and subjects with Inflammatory Bowel Disease.

Outcome Measures

Primary Outcome Measures :
  1. Fecal bile acid composition [ Time Frame: 5 days ]
    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

Secondary Outcome Measures :
  1. Microbiome diversity analysis [ Time Frame: 5 days ]
    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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464020

United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Byron P Vaughn, MD University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02464020     History of Changes
Other Study ID Numbers: 1504M69083
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Cholangitis, Sclerosing
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Bile Duct Diseases
Biliary Tract Diseases
Pathologic Processes
Bile Acids and Salts
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents