- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02828384
Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence
Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.
Background:
Fecal incontinence (FI) is a common complaint, and is often associated with diarrhea and urgency. Foods that are high in fermentable oligo-, di-, and mono-saccharides and polyols (FODMAPs) cause symptoms of diarrhea and urgency. Thus, assessing the impact of a low FODMAP diet in FI patients is needed.
Aims:
- Compare the treatment response with a low FODMAP vs. psyllium based on number of episodes in patients with FI.
- Compare the efficacy of a low FODMAP diet vs. psyllium in patients with FI on pre-specified clinical and quality of life endpoints.
Methods:
This is a prospective, randomized control trial of adults meeting the Rome III criteria for FI and at least 1 episode of FI due to loose stool per week. After a 2 week screening period and randomization, during which the severity of symptoms will be assessed and eligibility determined, patients will be randomized to psyllium vs. low FODMAP diet for 4 weeks. A total of 20 patients will be recruited for each arm.
The primary endpoint will be treatment response based on number of incontinence episodes. A treatment response is defined as a reduction in the number of FI episodes/week.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Experience at least 1 episode/week of unintentional loss of stool associated with diarrhea/loose stool (Bristol stool scale of 5 or greater).
- Subjects aged 18 and older meeting the Rome III criteria for Functional Fecal incontinence diagnostic criteria:
Recurrent uncontrolled passage of fecal material in an individual and one or more of the following:
- Abnormal functioning of normally innervated and structurally intact muscles
- Minor abnormalities of sphincter structure and/or innervation
- Normal or disordered bowel habits, (i.e., diarrhea) Criteria fulfilled for the last 3 months
Exclusion Criteria
- Abnormal innervation caused by lesion(s) within the brain (e.g., dementia), spinal cord, or sacral nerve roots, or mixed lesions (e.g., multiple sclerosis), or as part of a generalized peripheral or autonomic neuropathy
- Anal sphincter abnormalities associated with a multisystem disease (e.g., scleroderma)
- Structural or neurogenic abnormalities believed to be the major or primary cause of fecal incontinence
- Have cognitive dysfunction or unable to understand or provide written informed consent
- Pregnancy
- FI with solid stool only
- Comorbid medical problems that may affect gastrointestinal transit or motility: Inflammatory bowel disease, Extraintestinal disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.),Severe renal or hepatic disease
- Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery.
- . Previous treatment with low FODMAP diet.
- Concurrent medications not permitted including probiotics, antibiotics, and narcotics.
- Active participation in another form of dietary therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: low fodmap diet
Subjects receive formalized teaching in low fodmap diet by a dietician
|
dietary teaching
|
Active Comparator: psyllium
subjects receive 7.1 g of psyllium daily
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7.1g of psyllium daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in number of FI episodes from baseline to week 4
Time Frame: 4 weeks from baseline
|
Will compare baseline number of FI episodes to number of FI episodes at week 4
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4 weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of people responding with decreased score in stool consistency
Time Frame: 4 week span from baseline
|
For stool consistency, a responder with improvement will be defined as one who reports a decrease in mean daily BSFS value ( on a scale of 1-7 with 7 being watery stool) of 1 or more compared to baseline for ≥2 of 4 treatment weeks.
The proportion of responders between the 2 groups will be compared.
|
4 week span from baseline
|
number of people responding with reduction in stool frequency
Time Frame: 4 weeks from baseline
|
The number of bowel movements will be recorded each day.
Mean daily stool frequency will be averaged for each treatment group at baseline and weekly through week 4.
These averages will be compared for the two groups.
|
4 weeks from baseline
|
Change in stool wet weight
Time Frame: 4 weeks from baseline
|
The difference in stool mean wet weight between baseline and during week 4 will be calculated.
The change from baseline for each group will be compared.
|
4 weeks from baseline
|
Change in Fecal incontinence severity index (FISI)
Time Frame: 4 weeks from baseline
|
Compare baseline fecal incontinence severity index with 4 week FISI score.
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4 weeks from baseline
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Change in Fecal incontinence quality of life measure (FIqol)
Time Frame: 4 weeks from baseline
|
Compare baseline fecal incontinence quality of life with 4 week Fiqol score
|
4 weeks from baseline
|
Change in Short Form Health survey-36
Time Frame: 4 weeks from baseline
|
Compare baseline generalized QOL with 4 week SF-36
|
4 weeks from baseline
|
Number of participants with reduction in fecal incontinence episodes of ≥50% during weeks 3 & 4 of each diet compared with baseline
Time Frame: 4 weeks from baseline
|
Responders are those participants with a reduction in FI episodes of > 50%.
The reduction will be measured by the change in mean number of episodes in week 3 and 4 (averaged) from baseline.
|
4 weeks from baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stacy B Menees, MD, University of Michigan
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00079064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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