Fecal IncontinenceNCT04806386
The Role of Fiber in the Prevention and Treatment of Fecal Incontinence
A study testing Psyllium in people with Fecal Incontinence and Irritable Bowel Syndrome With Diarrhea, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of fiber supplementation on the fecal metagenome and metabolome in relation to symptoms and anorectal physiology in post-menopausal women with irritable bowel syndrome with diarrhea suffering from liquid stool fecal incontinence (FI.) Read more about this study
- Who is it for?
- Ages 50 to 90 years, women only
- Conditions the study is for
- Fecal Incontinence, Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Psyllium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2021to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, post-menopausal
- Age 50-90 years old
- BMI >18.5 and <40 kg/m2
- Rome IV criteria for liquid stool fecal incontinence occurring at least twice per month
- At least one FI episode during the run-in period
- Compliant with reporting during run-in (completion of two 3-day food diaries and two 7-day bowel diaries)
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- Submission of two stool samples during the run-in period
- Ability to follow verbal and written instructions
- Informed consent form signed by the subjects
Who cannot join
- Less than two episodes per month of liquid stool fecal incontinence
- Non-compliance with reporting during run-in
- Patients reporting laxative, enema, and/or suppository usage during the run-in period
- GI tract structural abnormality that would increase likelihood of obstruction
- Dysphagia, swallowing disorder, or history of esophageal structural lesions
- History of GI lumen surgery within 60 days prior to entry into the study
Show all 18Show fewer
- Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
- Inability to tolerate or contraindication to performance of anorectal manometry
- Celiac disease, Crohn's disease, ulcerative colitis
- Current anorectal fistula and/or abscess
- Age <50 or >90
- BMI of <18.5 or ≥40 kg/m2
- History of allergic reaction to psyllium
- Previous trial of soluble fiber supplementation for fecal incontinence within the previous 30 days
- History of sacral nerve stimulator or artificial anal sphincter placement
- Administration of investigational products within 1 month prior to Screening Visit
- Subjects anticipating surgical intervention during the study
- 19. History of intestinal stricture (e.g., Crohn's disease) 20. History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions 21. History of malabsorption 22. Any other clinically significant disease interfering with the assessments of psyllium, according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation) 23. Any relevant biochemical abnormality interfering with the assessments of psyllium, according to the Investigator 24. Patients with metallic implants within a 30 cm radius of the TAMS electromagnetic coil 25. Currently on opioids 26. Patients with severe cardiac disease, chronic renal failure, or previous GI surgery EXCEPT cholecystectomy, appendectomy, Nissen fundoplication, and partial colectomy 27. Patients with neurological diseases and increased intracranial pressure 28. Patients with impaired cognizance 29. Previous pelvic surgery/radiation, radical hysterectomy 30. Patients with Ulcerative Colitis or Crohn's Disease 31. History of or current rectal prolapse 32. Previous history of anal fissure, anal surgery (abscess), congenital anorectal malformation, fistulae or inflamed hemorrhoids 33. Pregnant women 34. Use of antibiotics in previous 60 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to determine the effect of fiber supplementation on the fecal metagenome and metabolome in relation to symptoms and anorectal physiology in post-menopausal women with irritable bowel syndrome with diarrhea suffering from liquid stool fecal incontinence (FI.)
Read the detailed description
This is an open-label, single-arm study at Massachusetts General Hospital that aims to recruit post-menopausal female patients with solid stool fecal incontinence. The investigators hope that subjects taking a daily fiber supplement will experience reduced episodes and symptoms of fecal incontinence, measured through quality of life questionnaires and daily stool and food diaries. Subjects will undergo 2 anorectal manometry procedures. Stool samples will also be collected for metabolomic and metagenomic analysis.
- Being tested
- Psyllium
- Keywords
- IBS-D, IBS, FI, Fecal Incontinence, Irritable Bowel Syndrome with Diarrhea, Irritable Bowel Syndrome
- Medical subject headings
- Fecal Incontinence, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsylliumDietary supplement
Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
| Study group | Role | What they receive |
|---|---|---|
| Psyllium fiber supplement treatment | Experimental | All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day. Receives: Dietary Supplement: Psyllium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stool Metagenomics Assessed by Sequence-based Microbial Communities and Rare Taxa
The Shannon Diversity Index is a measure of within-sample microbial diversity that incorporates both the number of microbial taxa present (i.e., richness) and the distribution of their relative abundances (i.e., evenness). It is calculated using the relative abundance of observed taxa within each stool sample. Higher values indicate greater microbial diversity. The theoretical minimum value is 0, and there is no fixed theoretical maximum because the upper bound depends on the number of taxa detected in a sample and sequencing depth. In human gut microbiome studies, observed values commonly range from approximately 2 to 6.
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Stool Butyrate Abundance Measured by Untargeted LC-MS Metabolomics
Butyrate was measured in stool samples using untargeted LC-MS metabolomics performed by Metabolon. Values were batch-normalized by dividing each sample value by the batch-specific median for butyrate, and missing values were imputed using the minimum observed value across batches. The resulting values were log-transformed before analysis. Higher values indicate greater relative abundance of butyrate in stool. Because this measure reflects relative abundance rather than absolute concentration, there is no fixed theoretical range.
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Secondary outcomes (9)
Change in Fecal Incontinence Severity Assessed by Fecal Incontinence Severity Index (FISI)
Questionnaire about the severity of symptoms in those with fecal incontinence. Consists of 4 questions, each rated on a scale of 1 to 6. Lower scores indicate higher severity of symptoms. (Min, 4, max 24)
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Fecal Incontinence Quality of Life Assessed by Fecal Incontinence Quality of Life (FIQL)
Questionnaire about the quality of life of those with fecal incontinence. Questions are rated from 1 to 4 in each of 4 sections. Lower rating represent worse quality of life and higher scores represent higher quality of life. (Min 4, max, 16)
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Anal Squeeze Pressure Assessed by Anorectal Manometry
Squeeze pressure assessed using a pressure sensory for Anorectal manometry (ARM) procedure performed to measure anal and rectal muscle function and sensation.
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Lumbo and Sacral Nerve Latency Assessed by Translumbosacral Anorectal Magnetic Stimulation
Translumbosacral anorectal magnetic stimulation (TAMS) performed during the ARM procedure to measure the change in the nerve conduction between the spinal cord and rectum.
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Relief Assessed by the Global Assessment of Relief
A 7-point scale indicating overall fecal incontinence symptom relief where 1 represents completely relieved and 7 represents completely worse.
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Bloating Scale Assessed by a Bloating Scale
A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity.
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Urgency Assessed by an Urgency Scale
A 10-point scale indicating urgency severity where 0 represents the least severity and 10 represents the most severity
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Flatus Assessed by a Flatus Scale
A 10-point scale indicating flatus severity where 0 represents the least severity and 10 represents the most severity
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Waist Circumference Measurement
A measure of the subject's waist circumference in the area where the most bloating is experienced
Measured: Change from baseline to final visit. Through study completion, up to 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start21 Jul 2021
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Kyle Staller, MD, MPH, Massachusetts General Hospital
- Investigators
- Kyle Staller, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806386
- Sponsor's protocol ID
- 2021P000691
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2021
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Fiber in the Prevention and Treatment of Fecal Incontinence
- ClinicalTrials.gov ID
- NCT04806386
- Acronym / sponsor ID
- 2021P000691
- Keywords
- IBS-D, IBS, FI, Fecal Incontinence, Irritable Bowel Syndrome with Diarrhea, Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of fiber supplementation on the fecal metagenome and metabolome in relation to symptoms and anorectal physiology in post-menopausal women with irritable bowel syndrome with diarrhea suffering from liquid stool fecal incontinence (FI.)
Detailed description
This is an open-label, single-arm study at Massachusetts General Hospital that aims to recruit post-menopausal female patients with solid stool fecal incontinence. The investigators hope that subjects taking a daily fiber supplement will experience reduced episodes and symptoms of fecal incontinence, measured through quality of life questionnaires and daily stool and food diaries. Subjects will undergo 2 anorectal manometry procedures. Stool samples will also be collected for metabolomic and metagenomic analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psyllium fiber supplement treatment | Experimental | Dietary Supplement: PsylliumAll patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female, post-menopausal
- Age 50-90 years old
- BMI >18.5 and <40 kg/m2
- Rome IV criteria for liquid stool fecal incontinence occurring at least twice per month
- At least one FI episode during the run-in period
Key exclusion criteria (18 listed)
- Less than two episodes per month of liquid stool fecal incontinence
- Non-compliance with reporting during run-in
- Patients reporting laxative, enema, and/or suppository usage during the run-in period
- GI tract structural abnormality that would increase likelihood of obstruction
- Dysphagia, swallowing disorder, or history of esophageal structural lesions
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 |
|---|---|---|
| PsylliumPsyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence. | Dietary supplement | Psyllium fiber supplement treatment |
Primary outcome
Change in Stool Metagenomics Assessed by Sequence-based Microbial Communities and Rare Taxa
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
The Shannon Diversity Index is a measure of within-sample microbial diversity that incorporates both the number of microbial taxa present (i.e., richness) and the distribution of their relative abundances (i.e., evenness). It is calculated using the relative abundance of observed taxa within each stool sample. Higher values indicate greater microbial diversity. The theoretical minimum value is 0, and there is no fixed theoretical maximum because the upper bound depends on the number of taxa detected in a sample and sequencing depth. In human gut microbiome studies, observed values commonly range from approximately 2 to 6.
Change in Stool Butyrate Abundance Measured by Untargeted LC-MS Metabolomics
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Butyrate was measured in stool samples using untargeted LC-MS metabolomics performed by Metabolon. Values were batch-normalized by dividing each sample value by the batch-specific median for butyrate, and missing values were imputed using the minimum observed value across batches. The resulting values were log-transformed before analysis. Higher values indicate greater relative abundance of butyrate in stool. Because this measure reflects relative abundance rather than absolute concentration, there is no fixed theoretical range.
9 secondary outcomes
Change in Fecal Incontinence Severity Assessed by Fecal Incontinence Severity Index (FISI)
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Fecal Incontinence Quality of Life Assessed by Fecal Incontinence Quality of Life (FIQL)
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Anal Squeeze Pressure Assessed by Anorectal Manometry
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Lumbo and Sacral Nerve Latency Assessed by Translumbosacral Anorectal Magnetic Stimulation
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Relief Assessed by the Global Assessment of Relief
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Bloating Scale Assessed by a Bloating Scale
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Urgency Assessed by an Urgency Scale
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Flatus Assessed by a Flatus Scale
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Waist Circumference Measurement
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kyle Staller, MD MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium in people with Fecal Incontinence and Irritable Bowel Syndrome With Diarrhea, run by Massachusetts General Hospital 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 9 inclusion and 18 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 30 Jun 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Stool Metagenomics Assessed by Sequence-based Microbial Communities and Rare Taxa (time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.