Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

Overview

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.

Full Title of Study: “Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2019

Interventions

  • Other: low fodmap diet
    • dietary teaching
  • Dietary Supplement: Psyllium
    • 7.1g of psyllium daily

Arms, Groups and Cohorts

  • Active Comparator: low fodmap diet
    • Subjects receive formalized teaching in low fodmap diet by a dietician
  • Active Comparator: psyllium
    • subjects receive 7.1 g of psyllium daily

Clinical Trial Outcome Measures

Primary Measures

  • Change in number of FI episodes from baseline to week 4
    • Time Frame: 4 weeks from baseline
    • Will compare baseline number of FI episodes to number of FI episodes at week 4

Secondary Measures

  • number of people responding with decreased score in stool consistency
    • Time Frame: 4 week span from baseline
    • For stool consistency, a responder with improvement will be defined as one who reports a decrease in mean daily BSFS value ( on a scale of 1-7 with 7 being watery stool) of 1 or more compared to baseline for ≥2 of 4 treatment weeks. The proportion of responders between the 2 groups will be compared.
  • number of people responding with reduction in stool frequency
    • Time Frame: 4 weeks from baseline
    • The number of bowel movements will be recorded each day. Mean daily stool frequency will be averaged for each treatment group at baseline and weekly through week 4. These averages will be compared for the two groups.
  • Change in stool wet weight
    • Time Frame: 4 weeks from baseline
    • The difference in stool mean wet weight between baseline and during week 4 will be calculated. The change from baseline for each group will be compared.
  • Change in Fecal incontinence severity index (FISI)
    • Time Frame: 4 weeks from baseline
    • Compare baseline fecal incontinence severity index with 4 week FISI score.
  • Change in Fecal incontinence quality of life measure (FIqol)
    • Time Frame: 4 weeks from baseline
    • Compare baseline fecal incontinence quality of life with 4 week Fiqol score
  • Change in Short Form Health survey-36
    • Time Frame: 4 weeks from baseline
    • Compare baseline generalized QOL with 4 week SF-36
  • Number of participants with reduction in fecal incontinence episodes of ≥50% during weeks 3 & 4 of each diet compared with baseline
    • Time Frame: 4 weeks from baseline
    • Responders are those participants with a reduction in FI episodes of > 50%. The reduction will be measured by the change in mean number of episodes in week 3 and 4 (averaged) from baseline.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Collaborator
    • The Rome Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stacy Menees, Assistant Professor – University of Michigan
  • Overall Official(s)
    • Stacy B Menees, MD, Principal Investigator, University of Michigan

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