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Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

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ClinicalTrials.gov Identifier: NCT02828384
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
The Rome Foundation
Information provided by (Responsible Party):
Stacy Menees, University of Michigan

Brief 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.


Condition or disease Intervention/treatment Phase
Fecal Incontinence Other: low fodmap diet Dietary Supplement: Psyllium Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.
Actual Study Start Date : October 2, 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: low fodmap diet
Subjects receive formalized teaching in low fodmap diet by a dietician
Other: low fodmap diet
dietary teaching

Active Comparator: psyllium
subjects receive 7.1 g of psyllium daily
Dietary Supplement: Psyllium
7.1g of psyllium daily




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Change in Fecal incontinence severity index (FISI) [ Time Frame: 4 weeks from baseline ]
    Compare baseline fecal incontinence severity index with 4 week FISI score.

  5. 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

  6. Change in Short Form Health survey-36 [ Time Frame: 4 weeks from baseline ]
    Compare baseline generalized QOL with 4 week SF-36

  7. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828384


Contacts
Contact: Stacy Menees, MD 734-936-6400 sbartnik@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Stacy Menees, MD, MS    734-936-6400    sbartnik@med.umich.edu   
Contact: Elaine Brady       embrady@med.umich.edu   
Sub-Investigator: William D Chey, MD         
Sub-Investigator: Dee E Fenner, MD         
Sub-Investigator: Shanti Eswaran, MD         
Sub-Investigator: Richard Saad, MD         
Sponsors and Collaborators
University of Michigan
The Rome Foundation
Investigators
Principal Investigator: Stacy B Menees, MD University of Michigan

Responsible Party: Stacy Menees, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02828384     History of Changes
Other Study ID Numbers: 00079064
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Keywords provided by Stacy Menees, University of Michigan:
fodmap diet

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Psyllium
Calcium polycarbophil
Cathartics
Gastrointestinal Agents
Antidiarrheals