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NCT02111603 · ClinicalTrials.gov registry record · Phase 4
Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT02111603: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT02111603 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02111603, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability of the HPLC assay for fecal bile acids to demonstrate responsiveness after treatment with Colesevelam.
Primary Outcome
Stool 48 hour collections (for BAs) were collected during baseline before treatment, and then during days 9-10 of the 10 days of colesevelam dosing for fecal BAs. Total fecal BA were measured using HPLC/tandem mass spectrometry.
Interventions
- DRUG Colesevelam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
What the finished NCT02111603 record still lists
NCT02111603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Colesevelam is the first listed.
NCT02111603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02111603 about?
NCT02111603 is a clinical study titled "Ability of Mayo Clinic High-performance Liquid Chromatography (HPLC) Method to Measure Fecal Bile Acids". The investigators' hypothesis is that therapy with Colesevelam, reduces fecal bile acid excretion in patients with Irritable Bowel Syndrome (IBS)-diarrhea with prior evidence of increased fecal 48 hour total bile acid excretion. The investigators aim to study the ability of the HPLC assay for fecal ...
What is the current status of trial NCT02111603?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2014-04. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02111603?
The interventions under investigation include: Colesevelam (DRUG).
Who is sponsoring clinical trial NCT02111603?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02111603's enrollment target sits among peer trials
13 1910th of 2000 higher than 88 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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