Clinical trial NCT02828384: Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence
Official title: Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fecal Incontinence
Keywords: fodmap diet
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: The Rome Foundation
First posted: 2016-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in number of FI episodes from baseline to week 4
timeFrame: 4 weeks from baseline
Secondary outcomes:
measure: number of people responding with decreased score in stool consistency
timeFrame: 4 week span from baseline
measure: number of people responding with reduction in stool frequency
timeFrame: 4 weeks from baseline
measure: Change in stool wet weight
timeFrame: 4 weeks from baseline
measure: Change in Fecal incontinence severity index (FISI)
timeFrame: 4 weeks from baseline
measure: Change in Fecal incontinence quality of life measure (FIqol)
timeFrame: 4 weeks from baseline
measure: Change in Short Form Health survey-36
timeFrame: 4 weeks from baseline
measure: Number of participants with reduction in fecal incontinence episodes of ≥50% during weeks 3 & 4 of each diet compared with baseline
timeFrame: 4 weeks from baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stacy B Menees, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menees SB, Jackson K, Baker JR, Fenner DE, Eswaran S, Nojkov B, Saad R, Lee AA, Chey WD. A Randomized Pilot Study to Compare the Effectiveness of a Low FODMAP Diet vs Psyllium in Patients With Fecal Incontinence and Loose Stools. Clin Transl Gastroenterol. 2022 Feb 19;13(3):e00454. doi: 10.14309/ctg.0000000000000454.