Fecal Incontinence Clinical Trial
Official title:
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:
1. Compare the treatment response with a low FODMAP vs. psyllium based on number of
episodes in patients with FI.
2. 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.
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