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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
OTHER	low fodmap diet	dietary teaching
DIETARY_SUPPLEMENT	Psyllium	7.1g of psyllium daily

Timeline

• Start date: 2014-10-02
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2016-07-11
• Last updated: 2019-08-28

Locations

1 site across 1 country: United States