Dietary Fiber for Fecal Incontinence
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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 Names:
|
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Other Outcome Measures
- 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
- usual diet intake []
written record of all food and drink consumed
- report of additional fluid intake []
subjects checked whether the drank required amount of additional fluid and wrote the date and time of drinking
- 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
- self-report of any stools not collected []
reported on stool diary daily with reason for not collecting
- 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
- 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.
- 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.
- Personal Goals of Treatment for Fecal Incontinence and Satisfaction with Achievement of Goals []
data obtained by semi-structured interview
- modifications of preparation of foods, diet intake, and eating pattern to manage fecal incontinence []
data obtained by semi-structured interview
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- University of Minnesota
Investigators
- Principal Investigator: Donna Z Bliss, phD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 010M69241
- R01NR007756-01A2