Dietary Fiber for Fecal Incontinence

Study Overview
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Brief Summary
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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).

Official Title
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The Impact of Fiber Fermentation on Fecal Incontinence

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Dietary Supplement: Psyllium
* Dietary Supplement: Gum Arabic
* Dietary Supplement: carboxymethylcellulose
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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. 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

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>basic recipe for juice and muffin recipe abbreviated PLB | Dietary Supplement: Placebo<br> <br> |
| Experimental: Carboxymethylcellulose<br>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 | Dietary Supplement: carboxymethylcellulose<br>* dietary fiber<br>|
| Experimental: Gum Arabic<br>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 | Dietary Supplement: Gum Arabic<br>* Gum acacia dietary fiber<br>* Other names: Gum acacia;|
| Experimental: Psyllium<br>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 | Dietary Supplement: Psyllium<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 
| 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. |  | 
| 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. |  | 
| 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. |  | 
| Self-report of amount of supplement consumed | reported by fractions on supplement intake form and return of unconsumed portion was assessed by study team |  | 
| amount of fecal incontinence | subjects self-reported greatest amount of soiling (from soling of tissue between buttocks to shoes or floor) |  | 
| 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 |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fecal incontinence, dietary fiber