Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Role of Fiber in the Prevention and Treatment of Fecal Incontinence

NCT04806386

Fecal Incontinence Irritable Bowel Syndrome With Diarrhea

COMPLETED NA

Dietary Fiber for Fecal Incontinence

NCT01738607

Fecal Incontinence

COMPLETED NA

Phase 2 Study to Evaluate Safety and Efficacy of RM-131 Administered to Patients With Chronic Constipation

NCT01781104

Constipation

COMPLETED PHASE2

Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

NCT00487422

Constipation

COMPLETED PHASE3

A Multi-centre, Phase II, Double-blind, Randomised, Placebo-controlled, Parallel Group, Dose-ranging Study in Patients With Faecal Incontinence; to Evaluate the Efficacy, Safety and Tolerability of Locally Applied NRL001 Over an 8 Week Treatment Period

NCT01656720

Faecal Incontinence

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Fecal Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

Fiber (psyllium) powder

Group Type ACTIVE_COMPARATOR

Psyllium powder

Intervention Type DRUG

2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)

Arm 2

Loperamide

Group Type ACTIVE_COMPARATOR

Loperamide

Intervention Type DRUG

1 capsule daily for 28 days (weekly adjusted dose)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psyllium powder

2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)

Intervention Type DRUG

Loperamide

1 capsule daily for 28 days (weekly adjusted dose)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Metamucil

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* weekly fecal incontinence

Exclusion Criteria

* fecal impaction
* inability to complete a baseline 1-week bowel diary
* rectal prolapse
* any prior radiation to the pelvis
* colo-rectal cancer
* rectal fistula
* inflammatory bowel disease
* neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)
* constipation (\<2 bowel movements/week) or total colectomy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No