CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 13 enrolled
Drug / intervention
Colesevelamdrug
Likely dose
Colesevelam 1875 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02111603
NCT02111603Phase 4Completed
CompareCT.gov

Ability of Mayo Clinic HPLC Method to Measure Fecal Bile Acids to Demonstrate Response to Colesevelam in Patients With Diarrhea Predominant Irritable Bowel Syndrome

Mayo Clinic·interventional·Posted Apr 11, 2014·Updated May 12, 2016

In Brief

A Phase 4 clinical trial evaluating Colesevelam for Diarrhea Predominant Irritable Bowel Syndrome. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea Predominant Irritable Bowel Syndrome
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 11, 2014
Enrollment StartApr 1, 2014
Primary CompletionAug 1, 2014
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.2 years ago

Interventions

Colesevelamdrug

Subjects will receive 1875 mg of Colesevelam orally twice daily for 10 days