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Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

Primary Purpose

Fecal Incontinence

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

low fodmap diet

Psyllium

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring fodmap diet

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

low fodmap diet

psyllium

Arm Description

Subjects receive formalized teaching in low fodmap diet by a dietician

subjects receive 7.1 g of psyllium daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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.

Change in Fecal incontinence severity index (FISI)

Compare baseline fecal incontinence severity index with 4 week FISI score.

Change in Fecal incontinence quality of life measure (FIqol)

Compare baseline fecal incontinence quality of life with 4 week Fiqol score

Change in Short Form Health survey-36

Compare baseline generalized QOL with 4 week SF-36

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.

Full Information

NCT ID

NCT02828384

First Posted

April 25, 2016

Last Updated

August 27, 2019

Sponsor

University of Michigan

Collaborators

The Rome Foundation

1. Study Identification

Unique Protocol Identification Number

NCT02828384

Brief Title

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

October 2, 2014 (Actual)

Primary Completion Date

June 2019 (Actual)

Study Completion Date

June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

The Rome Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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: Compare the treatment response with a low FODMAP vs. psyllium based on number of episodes in patients with FI. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fecal Incontinence

Keywords

fodmap diet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

low fodmap diet

Arm Type

Active Comparator

Arm Description

Subjects receive formalized teaching in low fodmap diet by a dietician

Arm Title

psyllium

Arm Type

Active Comparator

Arm Description

subjects receive 7.1 g of psyllium daily

Intervention Type

Other

Intervention Name(s)

low fodmap diet

Intervention Description

dietary teaching

Intervention Type

Dietary Supplement

Intervention Name(s)

Psyllium

Intervention Description

7.1g of psyllium daily

Primary Outcome Measure Information:

Title

Change in number of FI episodes from baseline to week 4

Description

Will compare baseline number of FI episodes to number of FI episodes at week 4

Time Frame

4 weeks from baseline

Secondary Outcome Measure Information:

Title

number of people responding with decreased score in stool consistency

Description

Time Frame

4 week span from baseline

Title

number of people responding with reduction in stool frequency

Description

Time Frame

4 weeks from baseline

Title

Change in stool wet weight

Description

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.

Time Frame

4 weeks from baseline

Title

Change in Fecal incontinence severity index (FISI)

Description

Compare baseline fecal incontinence severity index with 4 week FISI score.

Time Frame

4 weeks from baseline

Title

Change in Fecal incontinence quality of life measure (FIqol)

Description

Compare baseline fecal incontinence quality of life with 4 week Fiqol score

Time Frame

4 weeks from baseline

Title

Change in Short Form Health survey-36

Description

Compare baseline generalized QOL with 4 week SF-36

Time Frame

4 weeks from baseline

Title

Number of participants with reduction in fecal incontinence episodes of ≥50% during weeks 3 & 4 of each diet compared with baseline

Description

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.

Time Frame

4 weeks from baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stacy B Menees, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35060943

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.

Results Reference

derived

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Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence

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