Fecal IncontinenceNCT01738607
Dietary Fiber for Fecal Incontinence
A study testing Psyllium, Gum Arabic and carboxymethylcellulose in people with Fecal Incontinence, run by University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Psyllium, Gum Arabic and carboxymethylcellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Impact of Fiber Fermentation on Fecal Incontinence
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).
- Conditions
- Fecal Incontinence
- Being tested
- Psyllium, Gum Arabic, carboxymethylcellulose, Placebo
- Keywords
- fecal incontinence, dietary fiber
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsylliumDietary supplement
Gum ArabicDietary supplement
Also called Gum acacia
Gum acacia dietary fiber
carboxymethylcelluloseDietary supplement
dietary fiber
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | basic recipe for juice and muffin recipe
abbreviated PLB Receives: Dietary Supplement: Placebo |
| 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 Receives: Dietary Supplement: carboxymethylcellulose |
| 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 Receives: Dietary Supplement: Gum Arabic |
| 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 Receives: Dietary Supplement: Psyllium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (8)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startApr 2004
- Primary completionJun 2007
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna Z Bliss, phD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738607
- Sponsor's protocol ID
- 010M69241
- Other IDs
- R01NR007756-01A2
- Status last verified
- May 2023
- First submitted
- 21 Nov 2012
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Fiber Fermentation on Fecal Incontinence
- ClinicalTrials.gov ID
- NCT01738607
- Acronym / sponsor ID
- 010M69241
- Conditions
- Fecal Incontinence
- Keywords
- fecal incontinence, dietary fiber
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebobasic recipe for juice and muffin recipe abbreviated PLB |
| Carboxymethylcellulose | Experimental | Dietary Supplement: carboxymethylcelluloseThe 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 | Dietary Supplement: Gum ArabicThe 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 | Dietary Supplement: PsylliumThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- difficulty swallowing,
- a gastrointestinal (GI) tract altered by surgery,
- a malabsorption disorder,
- inflammatory bowel disease,
- gastrointestinal cancer or active cancer treatment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psyllium | Dietary supplement | Psyllium |
| Gum ArabicAlso: Gum acaciaGum acacia dietary fiber | Dietary supplement | Gum Arabic |
| carboxymethylcellulosedietary fiber | Dietary supplement | Carboxymethylcellulose |
| Placebo | Dietary supplement | Placebo |
Primary outcome
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
8 secondary outcomes
self-report of gastro-intestinal symptoms on a daily symptom record
self-report of quality of life
Water-holding capacity of non-frozen of stools
Gel formation of non-frozen stools
Total dietary fiber content of feces
Self-report of amount of supplement consumed
amount of fecal incontinence
wet and dry weights of collected stools and percentage of water content
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Z Bliss, phD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium, Gum Arabic and carboxymethylcellulose in people with Fecal Incontinence, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-report of an incontinent episode on a daily stool diary. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.