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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR007756-01A2 | U.S. NIH Grant/Contract | View source |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | basic recipe for juice and muffin recipe abbreviated PLB |
|
| Carboxymethylcellulose | Experimental | 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 |
|
| Gum Arabic | Experimental | 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 |
|
| Psyllium | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyllium | Dietary Supplement |
| ||
| Gum Arabic |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Z Bliss, phD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011620 | Psyllium |
| D006170 | Gum Arabic |
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Gum acacia dietary fiber |
|
|
| carboxymethylcellulose | Dietary Supplement | dietary fiber |
|
| Placebo | Dietary Supplement |
|
| 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 |
| 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 |
| D053149 |
| Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |