Clinical trial NCT01738607: Dietary Fiber for Fecal Incontinence
Official title: The Impact of Fiber Fermentation on Fecal Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fecal Incontinence
Keywords: fecal incontinence, dietary fiber
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-11-30
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: self-report of an incontinent episode on a daily stool diary
Secondary outcomes:
measure: self-report of gastro-intestinal symptoms on a daily symptom record
measure: self-report of quality of life
measure: Water-holding capacity of non-frozen of stools
measure: Gel formation of non-frozen stools
measure: Total dietary fiber content of feces
measure: Self-report of amount of supplement consumed
measure: amount of fecal incontinence
measure: wet and dry weights of collected stools and percentage of water content
Other outcomes:
measure: self-reported rating of consistency of continent stools on a daily stool diary
measure: usual diet intake
measure: report of additional fluid intake
measure: absorbent pad soiling
measure: self-report of any stools not collected
measure: Stool Color change
measure: in vitro fiber degradation
measure: total dietary fiber content of fiber sources used in Study
measure: Personal Goals of Treatment for Fecal Incontinence and Satisfaction with Achievement of Goals
measure: modifications of preparation of foods, diet intake, and eating pattern to manage fecal incontinence
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Donna Z Bliss, phD
role: PRINCIPAL_INVESTIGATOR
References: