Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Other: low fodmap diet
* Dietary Supplement: Psyllium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: low fodmap diet<br>Subjects receive formalized teaching in low fodmap diet by a dietician | Other: low fodmap diet<br>* dietary teaching<br>|
| Active Comparator: psyllium<br>subjects receive 7.1 g of psyllium daily | Dietary Supplement: Psyllium<br>* 7.1g of psyllium daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in number of FI episodes from baseline to week 4 | Will compare baseline number of FI episodes to number of FI episodes at week 4 | 4 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of people responding with decreased score in stool consistency | 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 | 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 | 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) | Compare baseline fecal incontinence severity index with 4 week FISI score. | 4 weeks from baseline | 
| Change in Fecal incontinence quality of life measure (FIqol) | Compare baseline fecal incontinence quality of life with 4 week Fiqol score | 4 weeks from baseline | 
| Change in Short Form Health survey-36 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fodmap diet