Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2014
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.
Epistemonikos ID: 994c2b18e3addc0c4f51e88f96b168c2840fb0a9
First added on: May 17, 2024