A Study of Colesevelam in Fecal Incontinence

Status Completed

Clinical Trial Summary

Compare the effects of a combination of colesevelam and clonidine to placebo on bowel symptoms in patients with urge or combined type of FI.

Clinical Trial Description

Fecal incontinence (FI) is a common symptom that can significantly impair quality of life. There is very limited, mostly uncontrolled, evidence to support the approaches currently used to manage FI. The alpha-2 adrenergic agonist clonidine decreased the frequency of loose stools in FI patients with diarrhea. Among patients with diarrhea, clonidine decreased the proportion of days with FI; however results were not statistically significant. Uncontrolled studies suggest that the bile acid binding resin colesevelam also increased stool consistency in patients with functional diarrhea. In this study, the investigators propose to compare the effects of a combination of colesevelam and clonidine to placebo on bowel symptoms in patients with urge or combined type of FI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02628626
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Completed
Phase	Phase 3
Start date	November 2015
Completion date	April 14, 2022

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