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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psyllium | Dietary Supplement | Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Change from baseline to final visit. Through study completion, up to 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Change from baseline to final visit. Through study completion, up to 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Staller, MD MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Psyllium Fiber Supplement Treatment | All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Psyllium Fiber Supplement Treatment | All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day. Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | Shannon Diversity Index | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Psyllium Fiber Supplement Treatment | All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day. Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital Admission | Nervous system disorders | Systematic Assessment | Participant admitted to ER for stroke like symptoms. The Principal Investigator and study team was informed through Epic notifications. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Cramping, Increased Bowel Movements, Anal Pain | Gastrointestinal disorders | Systematic Assessment | Patient reported new onset of abdominal cramping, pain/pressure in anus, and increased frequency of bowel movements a few days after beginning fiber bar treatment. Patient did not express desire to stop eating fiber bars. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyle Staller | Massachusetts General Hospital | 6177262000 | kstaller@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2024 | Apr 10, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 7, 2024 | Apr 10, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005242 | Fecal Incontinence |
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D011620 | Psyllium |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 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) | 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. | 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. | 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. | 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. | 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 | 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 | 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 | Change from baseline to final visit. Through study completion, up to 6 weeks. |
| Years |
|
| Sex: Female, Male | One participant did not complete the trial and therefore, their data was not analyzed. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day. Psyllium: Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence. |
|
|
|
| Primary | 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. | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | log(ratio) | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| Secondary | 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) | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | Score on a Scale | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| Secondary | 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) | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | Score on Scale | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| Secondary | 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. | 1 participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | mmHg | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| Secondary | 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. | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | Milliseconds | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| Secondary | 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. | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | Score on scale | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| Secondary | 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. | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | Score on Scale | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| Secondary | 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 | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | Score on a Scale | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| Secondary | 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 | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | Score on a Scale | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| Secondary | Change in Waist Circumference Measurement | A measure of the subject's waist circumference in the area where the most bloating is experienced | 1 Participant did not complete the study due to side effects from fiber bar consumption. | Posted | Mean | 95% Confidence Interval | Centimeters (cm) | Change from baseline to final visit. Through study completion, up to 6 weeks. |
|
|
|
|
| 0 |
| 31 |
| 1 |
| 31 |
| 5 |
| 31 |
|
|
| Constipation, Bloating | Gastrointestinal disorders | Systematic Assessment | Patient reports severe constipation and bloating, going a few days without a bowel movement. Patient is pausing fiber bars until has a BM. Dr. Staller was informed. Patient is anxious, but not too concerned. |
|
| Constipation, Bloating, Distention, Increased Gas | Gastrointestinal disorders | Systematic Assessment | Patient described constipation, bloating, distention, and increased gas at check-in 1. Patient advised by Dr. Staller to reduce intake to 1 bar per day and drink fluids. |
|
| Increased Reflux, Bloating | Gastrointestinal disorders | Systematic Assessment | Patient described increased reflux and bloating at week 3 check-in. Patient advised to reduce intake to 1.5 bars per day and drink more fluids |
|
| Bloating, Gas, Change in stool consistency | Gastrointestinal disorders | Systematic Assessment | Patient described increase in bloating, gas and change in stool consistency. Patient decided to stop taking the bars. Dr. Staller was informed. |
|
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| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |