Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

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

Detailed Description
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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.

Official Title
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Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Drug: Psyllium powder
* Drug: Loperamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Fiber (psyllium) powder | Drug: Psyllium powder<br>* 2 teaspoons with 8 ounces of liquid daily for 28 days (weekly adjusted dose)<br>* Other names: Metamucil;|
| Active Comparator: Arm 2<br>Loperamide | Drug: Loperamide<br>* 1 capsule daily for 28 days (weekly adjusted dose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day Bowel Diary, Number of Fecal Incontinence Episodes | After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). The mean number of total fecal incontinence episodes from a 7-day bowel diary from each time point was compared between the groups. | 6 weeks and 12 weeks | 
| Percentage of Bowel Movements With Incontinence | After consent, 7-day bowel diary was assessed at baseline (2-week visit), during the last week of the 4-week intervention (6-week visit), during the second week of the 2-week wash-out period at 8-weeks, and during the last week of the second 4-week intervention (12 weeks). We compared the percentage of the total number of fecal incontinence episodes over the total number of bowel movements from a 7-day bowel diary from each time point between the groups. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fecal Incontinence Severity Index Score, FISI | The patient-reported symptoms severity score, the Fecal Incontinence Severity Index (FISI), has 4 questions about the frequency of gas, mucus, liquid stool, and solid stool incontinence. Responses are weighted based on the patient rating of severity and a total score is calculated (range 0-61) with higher scores indicating a greater severity of symptoms. | baseline, 4 week and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal incontinence, adults, diarrhea