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Completed

NCT Number: NCT01738607

Dietary Fiber for 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).

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psyllium

Dietary Supplement

Gum Arabic

Dietary Supplement

Gum acacia dietary fiber

Other names: Gum acacia

carboxymethylcellulose

Dietary Supplement

dietary fiber

Placebo

Dietary Supplement

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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Self-report of amount of supplement consumed

    reported by fractions on supplement intake form and return of unconsumed portion was assessed by study team

  7. amount of fecal incontinence

    subjects self-reported greatest amount of soiling (from soling of tissue between buttocks to shoes or floor)

  8. 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 outcomes

  1. 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

  2. usual diet intake

    written record of all food and drink consumed

  3. report of additional fluid intake

    subjects checked whether the drank required amount of additional fluid and wrote the date and time of drinking

  4. 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

  5. self-report of any stools not collected

    reported on stool diary daily with reason for not collecting

  6. 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

  7. 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.

  8. 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.

  9. Personal Goals of Treatment for Fecal Incontinence and Satisfaction with Achievement of Goals

    data obtained by semi-structured interview

  10. modifications of preparation of foods, diet intake, and eating pattern to manage fecal incontinence

    data obtained by semi-structured interview

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

The Impact of Fiber Fermentation on Fecal Incontinence

Important dates

Study start
2004
Primary completion
2007
Study completion
2010
First posted
Nov 30, 2012
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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