Dietary Fiber for Fecal Incontinence

The Impact of Fiber Fermentation on Fecal Incontinence

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 Overview

• Status: Completed
• Conditions: Fecal Incontinence
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: carboxymethylcellulose; Dietary supplement: Gum Arabic; Dietary supplement: Psyllium

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; basic recipe for juice and muffin recipe abbreviated PLB	Dietary supplement: Placebo
Experimental: 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	Dietary supplement: carboxymethylcellulose; dietary fiber
Experimental: 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	Dietary supplement: Gum Arabic; Gum acacia dietary fiber; Other Names: Gum acacia
Experimental: 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	Dietary supplement: Psyllium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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
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

Other Outcome Measures

Outcome Measure	Measure Description
self-reported rating of consistency of continent stools on a daily stool diary	the Stool Consistency Classification System used was shown to be valid and reliable
usual diet intake	written record of all food and drink consumed
report of additional fluid intake	subjects checked whether the drank required amount of additional fluid and wrote the date and time of drinking
absorbent pad soiling	subjects indicated number of absorbent products that were soiled on stool diary and and saved and returned them to be assessed by study team
self-report of any stools not collected	reported on stool diary daily with reason for not collecting
Stool Color change	date and time a stool color change was observed after swallowing a capsule with a decoy or marker dose of a food dye; date and time capsule was taken was also reported
in vitro fiber degradation	nested experiment of in vitro degradation of each dietary fiber by stools of subjects using established procedure reported in Bliss, D.Z. et al. Nurs. Res. 2001, 50, 203-213.
total dietary fiber content of fiber sources used in Study	established method of Theander O. et al. J AOAC Int. 1995;78(4):1030-44 used.
Personal Goals of Treatment for Fecal Incontinence and Satisfaction with Achievement of Goals	data obtained by semi-structured interview
modifications of preparation of foods, diet intake, and eating pattern to manage fecal incontinence	data obtained by semi-structured interview

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Donna Z Bliss, phD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (Estimate): November 30, 2012

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: fecal incontinence, dietary fiber
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Fecal Incontinence; Gastrointestinal Agents; Cathartics; Laxatives; Carboxymethylcellulose Sodium; Psyllium
• Other Study ID Numbers: 010M69241; R01NR007756-01A2 (U.S. NIH Grant/Contract)