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Dietary Fiber for Fecal Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01738607
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : November 1, 2019
Information provided by (Responsible Party):
University of Minnesota

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).

Condition or disease Intervention/treatment Phase
Fecal Incontinence Dietary Supplement: Psyllium Dietary Supplement: Gum Arabic Dietary Supplement: carboxymethylcellulose Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Impact of Fiber Fermentation on Fecal Incontinence
Study Start Date : April 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Acacia

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 Name: 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

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01738607

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Donna Z Bliss, phD University of Minnesota

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Responsible Party: University of Minnesota Identifier: NCT01738607    
Other Study ID Numbers: 010M69241
R01NR007756-01A2 ( U.S. NIH Grant/Contract )
First Posted: November 30, 2012    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by University of Minnesota:
fecal incontinence, dietary fiber
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carboxymethylcellulose Sodium
Calcium polycarbophil
Gastrointestinal Agents