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NCT03201952 · ClinicalTrials.gov registry record · Phase 1
Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans
A Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT03201952: Clinical Trial Phase 1 study, sponsored by Vanderbilt University Medical Center.
NCT03201952 is a Phase 1 study that was terminated before completion, run by Vanderbilt University Medical Center. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03201952, a Phase 1 study, was terminated before completion, sponsored by Vanderbilt University Medical Center.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
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.
Primary Outcome
Following UDCA administration and a 2 hour period to allow steady state, a 3 hour glucose tolerance test will be completed while measuring glucose change from baseline.
Interventions
- DRUG Placebos
- DRUG Ursodeoxycholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2020-05-01 |
| Phase | Phase 1 |
Why NCT03201952 stopped before completion
NCT03201952 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03201952 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03201952 about?
NCT03201952 is a clinical study titled "Examination of the Metabolic Effects of Direct Bile Salt Delivery to the Ileum in Humans". 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.
What is the current status of trial NCT03201952?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2018-02-01. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT03201952?
The interventions under investigation include: Placebos (DRUG), Ursodeoxycholic Acid (DRUG).
Who is sponsoring clinical trial NCT03201952?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03201952's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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