Dietary Fiber for Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

The Impact of Fiber Fermentation on Fecal Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738607
• Other study ID #: 010M69241
• Secondary ID: R01NR007756-01A2
• Status: Completed
• Phase: N/A
• Start date: April 2004
• Est. completion date: December 2010

Study information

• Verified date: May 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: December 2010
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Dietary Supplement:
• Psyllium

• Gum Arabic
Gum acacia dietary fiber
• carboxymethylcellulose
dietary fiber
• Placebo

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	usual diet intake	written record of all food and drink consumed
Other	report of additional fluid intake	subjects checked whether the drank required amount of additional fluid and wrote the date and time of drinking
Other	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
Other	self-report of any stools not collected	reported on stool diary daily with reason for not collecting
Other	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
Other	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.
Other	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.
Other	Personal Goals of Treatment for Fecal Incontinence and Satisfaction with Achievement of Goals	data obtained by semi-structured interview
Other	modifications of preparation of foods, diet intake, and eating pattern to manage fecal incontinence	data obtained by semi-structured interview
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Self-report of amount of supplement consumed	reported by fractions on supplement intake form and return of unconsumed portion was assessed by study team
Secondary	amount of fecal incontinence	subjects self-reported greatest amount of soiling (from soling of tissue between buttocks to shoes or floor)
Secondary	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