Clinical Trial: Dietary Fiber for Fecal Incontinence

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Impact of Fiber Fermentation on Fecal Incontinence

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).

Detailed Summary:
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: November 21, 2012
Date Started: April 2004
Date Completion:
Last Updated: October 29, 2015
Last Verified: October 2015