Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

Completed · Phase 2

Conditions studied: Fecal Incontinence

In brief

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.

Key facts

Study ID

NCT02828384

Run by

University of Michigan

People needed

40

Starts

2014-10-02

Expected to finish

2019-06-01

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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