Fecal IncontinencePhase 2NCT02828384
Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence
A Phase 2 study testing low fodmap diet and Psyllium in people with Fecal Incontinence, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- low fodmap diet and Psyllium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2014to Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Fecal Incontinence
- Being tested
- low fodmap diet, Psyllium
- Keywords
- fodmap diet
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low fodmap dietOther
dietary teaching
PsylliumDietary supplement
7.1g of psyllium daily
| Study group | Role | What they receive |
|---|---|---|
| low fodmap diet | Active comparator | Subjects receive formalized teaching in low fodmap diet by a dietician Receives: Other: low fodmap diet |
| psyllium | Active comparator | subjects receive 7.1 g of psyllium daily Receives: Dietary Supplement: Psyllium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks from baseline
Secondary outcomes (7)
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.
Measured: 4 week span from baseline
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.
Measured: 4 weeks from baseline
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.
Measured: 4 weeks from baseline
Change in Fecal incontinence severity index (FISI)
Compare baseline fecal incontinence severity index with 4 week FISI score.
Measured: 4 weeks from baseline
Change in Fecal incontinence quality of life measure (FIqol)
Compare baseline fecal incontinence quality of life with 4 week Fiqol score
Measured: 4 weeks from baseline
Change in Short Form Health survey-36
Compare baseline generalized QOL with 4 week SF-36
Measured: 4 weeks from baseline
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.
Measured: 4 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start2 Oct 2014
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- The Rome Foundation
- Responsible party
- Principal investigator, Stacy Menees, University of Michigan
- Investigators
- Stacy B Menees, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828384
- Sponsor's protocol ID
- 00079064
- Status last verified
- Aug 2019
- First submitted
- 25 Apr 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35060943
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effectiveness of Two Dietary Interventions for Fecal Incontinence: a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT02828384
- Acronym / sponsor ID
- 00079064
- Conditions
- Fecal Incontinence
- Keywords
- fodmap diet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- The Rome Foundation
- Study start
- 2 Oct 2014 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low fodmap diet | Active comparator | Other: low fodmap dietSubjects receive formalized teaching in low fodmap diet by a dietician |
| psyllium | Active comparator | Dietary Supplement: Psylliumsubjects receive 7.1 g of psyllium daily |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low fodmap dietdietary teaching | Other | low fodmap diet |
| Psyllium7.1g of psyllium daily | Dietary supplement | psyllium |
Primary outcome
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
7 secondary outcomes
number of people responding with decreased score in stool consistency
Time frame: 4 week span from baseline
number of people responding with reduction in stool frequency
Time frame: 4 weeks from baseline
Change in stool wet weight
Time frame: 4 weeks from baseline
Change in Fecal incontinence severity index (FISI)
Time frame: 4 weeks from baseline
Change in Fecal incontinence quality of life measure (FIqol)
Time frame: 4 weeks from baseline
Change in Short Form Health survey-36
Time frame: 4 weeks from baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 35060943Menees 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy B Menees, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing low fodmap diet and Psyllium in people with Fecal Incontinence, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of FI episodes from baseline to week 4 (time frame: 4 weeks from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.