CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Colesevelam +1 moredrug
Likely dose
Not stated in 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/NCT03270085
NCT03270085Phase 2Completed
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Randomized, Double Blinded, Placebo Controlled Trial to Understand Efficacy of Colesevelam in Diarrhea Predominant IBS Patients With Bile Acid Malabsorption

Mayo Clinic·interventional·Posted Sep 1, 2017·Updated Apr 27, 2020

In Brief

A Phase 2 clinical trial evaluating Colesevelam and Placebo for Chronic Diarrhea and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

To compare with a randomized trial (n=15 per treatment group), effects of colesevelam and placebo treatment, on colonic transit, bowel functions, permeability and tight junction expression in rectosigmoid mucosa of IBS-D with Bile Acid Malabsorption.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Diarrhea, Irritable Bowel Syndrome With Diarrhea, Bile Acid Malabsorption
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 1, 2017
Enrollment StartDec 7, 2017
Primary CompletionMay 31, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.8 years ago

Interventions

Colesevelamdrug

Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational.

Placeboother

A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug.