Dietary Fiber for Fecal Incontinence

Not Applicable

Completed

• Conditions: Fecal Incontinence
• Interventions: Dietary Supplement: Gum Arabic; Dietary Supplement: carboxymethylcellulose; Dietary Supplement: Psyllium; Dietary Supplement: Placebo

• Registration Number: NCT01738607
• Lead Sponsor: University of Minnesota

Brief Summary

The primary aim of this study was to compare the effects of supplementation with one of three dietary fibers (gum arabic, carboxy-methylcellulose, or psyllium) or a placebo on fecal incontinence (FI), symptom intolerance, and quality of life in community-living individuals who have incontinence of loose or liquid feces. A secondary aim was to explore the possible mechanism(s) underlying the supplements' efficacy (i.e., improvements in stool consistency, water-holding capacity or gel formation).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2007-06
• Study Completion: 2010-12
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• age ≥18 years
• living in the community (not a nursing home or assisted living facility)
• self-report of usually having FI of loose or liquid consistency at least twice in a 2-wk period
• toilets independently
• ability to read and write in English.
• Persons that regularly performed pelvic floor muscle exercises and/or biofeedback on a maintenance regimen for at least 20 wks or who took a steady dose of anti-motility medications on a regular schedule that still met the FI criteria were also eligible.

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Exclusion Criteria

• difficulty swallowing,
• a gastrointestinal (GI) tract altered by surgery,
• a malabsorption disorder,
• inflammatory bowel disease,
• gastrointestinal cancer or active cancer treatment,
• allergy to the fibers,
• regularly used a laxative or enema, were tube-fed, or unwilling to discontinue taking periodic self-prescribed fiber supplements or anti-diarrheal medications.
• a score ≤24 on the Mini Mental State Examination
• having/reporting fewer than two episodes of FI or being incapable of performing study procedures during the run-in baseline period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Gum Arabic	Gum Arabic	The supplements were prepared as two fruit juice mixtures (each 270 ml) providing 7 g total fiber/d) and two small muffins providing 9 g total fiber/d for 16 g of toal fiber daily. abbreviated GA
Carboxymethylcellulose	carboxymethylcellulose	The supplements were prepared as two fruit juice mixtures (each 270 ml) providing 7 g total fiber/d) and two small muffins providing 9 g total fiber/d for 16 g of toal fiber daily. abbreviated CMC
Psyllium	Psyllium	The supplements were prepared as two fruit juice mixtures (each 270 ml) providing 7 g total fiber/d) and two small muffins providing 9 g total fiber/d for 16 g of toal fiber daily. abbreviated as PSY
Placebo	Placebo	basic recipe for juice and muffin recipe abbreviated PLB

Primary Outcome Measures

Name	Time	Method
self-report of an incontinent episode on a daily stool diary		the date and time of an incontinence episode was reported and the ratio of the number of incontinence episodes to total stools daily was calculated

Secondary Outcome Measures

Name	Time	Method
amount of fecal incontinence		subjects self-reported greatest amount of soiling (from soling of tissue between buttocks to shoes or floor)
self-report of gastro-intestinal symptoms on a daily symptom record		The amount of GI symptoms reported were flatus, belching, bloating, abdominal cramping, nausea, a feeling of fullness, and stomach upset using a categorical scale. Number of times of flatus was also reported.; The amount of two obfuscating symptoms were also reported. headache and sleepiness.; How upsetting/bothersome the symptoms were were also reported.
Total dietary fiber content of feces		Measured in composites of all stools from baseline and supplement periods and non-frozen stools; Established method of Theander O, et al. J AOAC Int. 1995;78(4):1030-44 used.
wet and dry weights of collected stools and percentage of water content		collected stools were weighed and freeze-dried to constant weight; percentage of water content was calculated from these values
Gel formation of non-frozen stools		Measure was done on stools of 52 randomly selected subjects (13 from each group); Established method of Fischer, M.H. et al.Carbohydrate Research 2004;339(11): 2009-2017.
self-report of quality of life		The Fecal Incontinence Quality of Life tool (FIQL) was used; Rockwood, T.H. et al. Diseases of the Colon \& Rectum. 2000;43(1):9-16.
Water-holding capacity of non-frozen of stools		Measure was done on stools of 52 randomly selected subjects (13 from each group) Established method of Wenzl, H. et al. Gastroenterology. 1995;108(6):1729-38 used.
Self-report of amount of supplement consumed		reported by fractions on supplement intake form and return of unconsumed portion was assessed by study team

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States