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Completed

NCT Number: NCT02828384

Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

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.

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Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Low fodmap diet

Other

dietary teaching

Psyllium

Dietary Supplement

7.1g of psyllium daily

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • The Rome Foundation

Registry information

Official study title

Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2016
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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