Dietary Fiber for Fecal Incontinence

University of Minnesota206 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

206

Conditions

Fecal Incontinence

Interventions

PsylliumDIETARY_SUPPLEMENT

Gum ArabicDIETARY_SUPPLEMENT

Gum acacia dietary fiber

carboxymethylcelluloseDIETARY_SUPPLEMENT

dietary fiber

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.