Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 12/13/2018 |
| Start Date: | October 2, 2014 |
| End Date: | March 2019 |
| Contact: | Stacy Menees, MD |
| Email: | sbartnik@med.umich.edu |
| Phone: | 734-936-6400 |
Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.
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.
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.
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.
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