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Dietary Fiber for Fecal Incontinence

Primary Purpose

Fecal Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psyllium
Gum Arabic
carboxymethylcellulose
Placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring fecal incontinence, dietary fiber

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Carboxymethylcellulose

Gum Arabic

Psyllium

Arm Description

basic recipe for juice and muffin recipe abbreviated PLB

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

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

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

Outcomes

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

Full Information

First Posted
November 21, 2012
Last Updated
May 8, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01738607
Brief Title
Dietary Fiber for Fecal Incontinence
Official Title
The Impact of Fiber Fermentation on Fecal Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fecal Incontinence
Keywords
fecal incontinence, dietary fiber

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
basic recipe for juice and muffin recipe abbreviated PLB
Arm Title
Carboxymethylcellulose
Arm Type
Experimental
Arm Description
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
Arm Title
Gum Arabic
Arm Type
Experimental
Arm Description
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
Arm Title
Psyllium
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyllium
Intervention Type
Dietary Supplement
Intervention Name(s)
Gum Arabic
Other Intervention Name(s)
Gum acacia
Intervention Description
Gum acacia dietary fiber
Intervention Type
Dietary Supplement
Intervention Name(s)
carboxymethylcellulose
Intervention Description
dietary fiber
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
self-report of an incontinent episode on a daily stool diary
Description
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 Measure Information:
Title
self-report of gastro-intestinal symptoms on a daily symptom record
Description
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.
Title
self-report of quality of life
Description
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.
Title
Water-holding capacity of non-frozen of stools
Description
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.
Title
Gel formation of non-frozen stools
Description
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.
Title
Total dietary fiber content of feces
Description
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.
Title
Self-report of amount of supplement consumed
Description
reported by fractions on supplement intake form and return of unconsumed portion was assessed by study team
Title
amount of fecal incontinence
Description
subjects self-reported greatest amount of soiling (from soling of tissue between buttocks to shoes or floor)
Title
wet and dry weights of collected stools and percentage of water content
Description
collected stools were weighed and freeze-dried to constant weight; percentage of water content was calculated from these values
Other Pre-specified Outcome Measures:
Title
self-reported rating of consistency of continent stools on a daily stool diary
Description
the Stool Consistency Classification System used was shown to be valid and reliable
Title
usual diet intake
Description
written record of all food and drink consumed
Title
report of additional fluid intake
Description
subjects checked whether the drank required amount of additional fluid and wrote the date and time of drinking
Title
absorbent pad soiling
Description
subjects indicated number of absorbent products that were soiled on stool diary and and saved and returned them to be assessed by study team
Title
self-report of any stools not collected
Description
reported on stool diary daily with reason for not collecting
Title
Stool Color change
Description
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
Title
in vitro fiber degradation
Description
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.
Title
total dietary fiber content of fiber sources used in Study
Description
established method of Theander O. et al. J AOAC Int. 1995;78(4):1030-44 used.
Title
Personal Goals of Treatment for Fecal Incontinence and Satisfaction with Achievement of Goals
Description
data obtained by semi-structured interview
Title
modifications of preparation of foods, diet intake, and eating pattern to manage fecal incontinence
Description
data obtained by semi-structured interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Z Bliss, phD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Dietary Fiber for Fecal Incontinence

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