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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Glucose Intolerance, Gastric Bypass Surgery

In brief

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.

Key facts

Study ID

NCT03201952

Run by

Vanderbilt University Medical Center

People needed

2

Starts

2018-02-01

Expected to finish

2020-05-01

Last updated by the study team

2021-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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