NCT00727649

Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.

Detailed description

Fecal incontinence (FI) affects 4-24% adults in the community and greatly impacts quality of life. Both fiber and loperamide are common, first-line treatments for diarrhea-associated FI in primary care. No known studies exist that compare fiber and loperamide for diarrhea-predominant FI. Further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for FI. This study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DRUG	Psyllium powder	2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)
DRUG	Loperamide	1 capsule daily for 28 days (weekly adjusted dose)

Timeline

• Start date: 2008-07-01
• Primary completion: 2013-10-01
• Completion: 2013-12-01
• First posted: 2008-08-04
• Last updated: 2015-04-01
• Results posted: 2015-04-01

Locations

1 site across 1 country: United States