Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans

• Status: Terminated
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This project will evaluate distal intestinal bile salt administration in humans by deliving ursodeoxycholic acid (UDCA) into the terminal ileum of subjects with a pre-existing ileostomy and assessing several hormone levels following an oral glucose tolerance test compared to a placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Treatments: Bile Acids and Salts; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• Able to give informed consent

• Presence of an ileostomy > 2 months

• Weight stable* for >2 months (i.e. no greater than 7% change in body weight the last 2 months)

Exclusion Criteria:

• Crohn's Disease

• Steroid use in the last 3 months

• Documented/known diagnosis of type 1 diabetes or type 2 diabetes, chronic liver disease, chronic kidney disease, heart failure, cardiac dysrhythmias, or familial hypercholesterolemia

• Current use of any over-the-counter or prescription oral bile salt

• Currently pregnant

• Current use of medications that are known to interact with Ursodiol

• Current or former smoker within the last year.