Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence
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|ClinicalTrials.gov Identifier: NCT02828384|
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : December 11, 2018
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.
- 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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Other: low fodmap diet Dietary Supplement: Psyllium||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.|
|Actual Study Start Date :||October 2, 2014|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
Active Comparator: low fodmap diet
Subjects receive formalized teaching in low fodmap diet by a dietician
Other: low fodmap diet
Active Comparator: psyllium
subjects receive 7.1 g of psyllium daily
Dietary Supplement: Psyllium
7.1g of psyllium daily
- 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
- 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.
- 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.
- 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.
- Change in Fecal incontinence severity index (FISI) [ Time Frame: 4 weeks from baseline ]Compare baseline fecal incontinence severity index with 4 week FISI score.
- 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
- Change in Short Form Health survey-36 [ Time Frame: 4 weeks from baseline ]Compare baseline generalized QOL with 4 week SF-36
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828384
|Contact: Stacy Menees, MDemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Stacy Menees, MD, MS 734-936-6400 firstname.lastname@example.org|
|Contact: Elaine Brady email@example.com|
|Sub-Investigator: William D Chey, MD|
|Sub-Investigator: Dee E Fenner, MD|
|Sub-Investigator: Shanti Eswaran, MD|
|Sub-Investigator: Richard Saad, MD|
|Principal Investigator:||Stacy B Menees, MD||University of Michigan|