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
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 lifeThe 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 stoolsMeasure 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 stoolsMeasure 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 consumedreported by fractions on supplement intake form and return of unconsumed portion was assessed by study team
- amount of fecal incontinencesubjects 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 contentcollected 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