Dietary Fiber for Fecal Incontinence

University of Minnesota (UMN)

Status: Completed

Conditions: Fecal Incontinence

Treatments: Dietary Supplement: Psyllium; Dietary Supplement: Gum Arabic; Dietary Supplement: carboxymethylcellulose; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01738607

010M69241

R01NR007756-01A2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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206 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

basic recipe for juice and muffin recipe abbreviated PLB

Treatment:

Dietary Supplement: Placebo

Carboxymethylcellulose

Experimental group

Description:

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

Treatment:

Dietary Supplement: carboxymethylcellulose

Gum Arabic

Experimental group

Description:

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

Treatment:

Dietary Supplement: Gum Arabic

Psyllium

Experimental group

Description:

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

Treatment:

Dietary Supplement: Psyllium