Dietary Fiber for Fecal Incontinence

NCT01738607 | Completed DMC

• 2 other identifiers: 010M69241R01NR007756-01A2
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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).

Conditions

Fecal Incontinence

Keywords

fecal incontinence, dietary fiber

Outcome Measures

Primary Outcomes (1)

• 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 (8)

• self-report of gastro-intestinal symptoms on a daily symptom record

• self-report of quality of life

• Water-holding capacity of non-frozen of stools

• Gel formation of non-frozen stools

• Total dietary fiber content of feces

Other Outcomes (10)

• self-reported rating of consistency of continent stools on a daily stool diary

• usual diet intake

• report of additional fluid intake

Study Arms (4)

Placebo

PLACEBO COMPARATOR

basic recipe for juice and muffin recipe abbreviated PLB

Dietary Supplement: Placebo

Carboxymethylcellulose

EXPERIMENTAL

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

Gum Arabic

EXPERIMENTAL

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

Psyllium

EXPERIMENTAL

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

Interventions

Psyllium DIETARY_SUPPLEMENT

Psyllium

Gum Arabic DIETARY_SUPPLEMENT

Gum acacia dietary fiber

Also known as: Gum acacia

Gum Arabic

carboxymethylcellulose DIETARY_SUPPLEMENT

dietary fiber

Carboxymethylcellulose

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Interventions

Psyllium; Gum Arabic; Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Methylcellulose; Cellulose; Glucans

Study Officials

• Donna Z Bliss, phD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 30, 2012
• Study Start: April 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: December 1, 2010
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

US (1)