Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

University of Michigan

Status and phase: Completed; Phase 2

Conditions: Fecal Incontinence

Treatments: Other: low fodmap diet; Dietary Supplement: Psyllium

Study type: Interventional

Funder types: Other

Identifiers

NCT02828384

00079064

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Experience at least 1 episode/week of unintentional loss of stool associated with diarrhea/loose stool (Bristol stool scale of 5 or greater).
2. 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:

1. Abnormal functioning of normally innervated and structurally intact muscles
2. Minor abnormalities of sphincter structure and/or innervation
3. Normal or disordered bowel habits, (i.e., diarrhea) Criteria fulfilled for the last 3 months

Exclusion Criteria

1. 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
2. Anal sphincter abnormalities associated with a multisystem disease (e.g., scleroderma)
3. Structural or neurogenic abnormalities believed to be the major or primary cause of fecal incontinence
4. Have cognitive dysfunction or unable to understand or provide written informed consent
5. Pregnancy
6. FI with solid stool only
7. 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
8. Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery.
9. . Previous treatment with low FODMAP diet.
10. Concurrent medications not permitted including probiotics, antibiotics, and narcotics.
11. Active participation in another form of dietary therapy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

low fodmap diet

Active Comparator group

Description:

Subjects receive formalized teaching in low fodmap diet by a dietician

Treatment:

Other: low fodmap diet

psyllium

Active Comparator group

Description:

subjects receive 7.1 g of psyllium daily

Treatment:

Dietary Supplement: Psyllium