Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02828384
• Other study ID #: 00079064
• Status: Completed
• Phase: Phase 2
• Start date: October 2, 2014
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Other:
• low fodmap diet
dietary teaching

Dietary Supplement:
• Psyllium
7.1g of psyllium daily

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	The Rome Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of FI episodes from baseline to week 4	Will compare baseline number of FI episodes to number of FI episodes at week 4	4 weeks from baseline
Secondary	number of people responding with decreased score in stool consistency	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.	4 week span from baseline
Secondary	number of people responding with reduction in stool frequency	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.	4 weeks from baseline
Secondary	Change in stool wet weight	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 weeks from baseline
Secondary	Change in Fecal incontinence severity index (FISI)	Compare baseline fecal incontinence severity index with 4 week FISI score.	4 weeks from baseline
Secondary	Change in Fecal incontinence quality of life measure (FIqol)	Compare baseline fecal incontinence quality of life with 4 week Fiqol score	4 weeks from baseline
Secondary	Change in Short Form Health survey-36	Compare baseline generalized QOL with 4 week SF-36	4 weeks from baseline
Secondary	Number of participants with reduction in fecal incontinence episodes of =50% during weeks 3 & 4 of each diet compared with 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.	4 weeks from baseline