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Dietary Fiber for Fecal Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01738607
First received: November 21, 2012
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Fecal Incontinence
 Dietary Supplement: Psyllium
Dietary Supplement: Gum Arabic
Dietary Supplement: carboxymethylcellulose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Impact of Fiber Fermentation on Fecal Incontinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • self-report of an incontinent episode on a daily stool diary [ Designated as safety issue: No ]
    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:
  • self-report of gastro-intestinal symptoms on a daily symptom record [ Designated as safety issue: No ]

    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]

    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 [ Designated as safety issue: No ]
    reported by fractions on supplement intake form and return of unconsumed portion was assessed by study team

  • amount of fecal incontinence [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    collected stools were weighed and freeze-dried to constant weight; percentage of water content was calculated from these values


Other Outcome Measures:
  • self-reported rating of consistency of continent stools on a daily stool diary [ Designated as safety issue: No ]
    the Stool Consistency Classification System used was shown to be valid and reliable

  • usual diet intake [ Designated as safety issue: No ]
    written record of all food and drink consumed

  • report of additional fluid intake [ Designated as safety issue: No ]
    subjects checked whether the drank required amount of additional fluid and wrote the date and time of drinking

  • absorbent pad soiling [ Designated as safety issue: No ]
    subjects indicated number of absorbent products that were soiled on stool diary and and saved and returned them to be assessed by study team

  • self-report of any stools not collected [ Designated as safety issue: No ]
    reported on stool diary daily with reason for not collecting

  • Stool Color change [ Designated as safety issue: No ]
    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

  • in vitro fiber degradation [ Designated as safety issue: No ]
    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.

  • total dietary fiber content of fiber sources used in Study [ Designated as safety issue: No ]
    established method of Theander O. et al. J AOAC Int. 1995;78(4):1030-44 used.

  • Personal Goals of Treatment for Fecal Incontinence and Satisfaction with Achievement of Goals [ Designated as safety issue: No ]
    data obtained by semi-structured interview

  • modifications of preparation of foods, diet intake, and eating pattern to manage fecal incontinence [ Designated as safety issue: No ]
    data obtained by semi-structured interview


Enrollment: 206
Study Start Date: April 2004
Study Completion Date: December 2010
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo

basic recipe for juice and muffin recipe

abbreviated PLB
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01738607

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Donna Z Bliss, phD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01738607     History of Changes
Other Study ID Numbers: R01-NR07756, R01NR07756-01A2
Study First Received: November 21, 2012
Last Updated: November 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
fecal incontinence, dietary fiber

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Carboxymethylcellulose Sodium
Calcium polycarbophil
 Psyllium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Cathartics
Antidiarrheals

ClinicalTrials.gov processed this record on May 21, 2013