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

NCT03201952 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-04-20

No results posted yet for this study

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.

Conditions

  • Glucose Intolerance
  • Gastric Bypass Surgery

Interventions

DRUG

Ursodeoxycholic Acid

Ileostomy administration of 300mg UDCA once

DRUG

Placebos

Ileostomy administration of 5cc saline placebo once

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Naji Abumrad, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2020-05-01
Completion
2020-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201952 on ClinicalTrials.gov