Fecal Incontinence, Irritable Bowel Syndrome With Diarrhea
Conditions
Keywords
IBS-D, IBS, FI, Fecal Incontinence, Irritable Bowel Syndrome with Diarrhea, Irritable Bowel Syndrome
Brief 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.)
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.
Interventions
DIETARY_SUPPLEMENTPsyllium
Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
Sponsors
Massachusetts General Hospital
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Female, post-menopausal 2. Age 50-90 years old 3. BMI \>18.5 and \<40 kg/m2 4. Rome IV criteria for liquid stool fecal incontinence occurring at least twice per month 5. At least one FI episode during the run-in period 6. Compliant with reporting during run-in (completion of two 3-day food diaries and two 7-day bowel diaries) 7. Submission of two stool samples during the run-in period 8. Ability to follow verbal and written instructions 9. Informed consent form signed by the subjects
Exclusion criteria
1. Less than two episodes per month of liquid stool fecal incontinence 2. Non-compliance with reporting during run-in 3. Patients reporting laxative, enema, and/or suppository usage during the run-in period 4. GI tract structural abnormality that would increase likelihood of obstruction 5. Dysphagia, swallowing disorder, or history of esophageal structural lesions 6. History of GI lumen surgery within 60 days prior to entry into the study 7. Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study 8. Inability to tolerate or contraindication to performance of anorectal manometry 9. Celiac disease, Crohn's disease, ulcerative colitis 10. Current anorectal fistula and/or abscess 11. Age \<50 or \>90 12. BMI of \<18.5 or ≥40 kg/m2 13. History of allergic reaction to psyllium 14. Previous trial of soluble fiber supplementation for fecal incontinence within the previous 30 days 15. History of sacral nerve stimulator or artificial anal sphincter placement 16. Administration of investigational products within 1 month prior to Screening Visit 17. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stool Metagenomics Assessed by Sequence-based Microbial Communities and Rare Taxa | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal Incontinence Severity Assessed by Fecal Incontinence Severity Index (FISI) | Change from baseline to final visit. Through study completion, up to 6 weeks. | 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 in Fecal Incontinence Quality of Life Assessed by Fecal Incontinence Quality of Life (FIQL) | Change from baseline to final visit. Through study completion, up to 6 weeks. | 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 in Anal Squeeze Pressure Assessed by Anorectal Manometry | Change from baseline to final visit. Through study completion, up to 6 weeks. | Squeeze pressure assessed using a pressure sensory for Anorectal manometry (ARM) procedure performed to measure anal and rectal muscle function and sensation. |
| Change in Lumbo and Sacral Nerve Latency Assessed by Translumbosacral Anorectal Magnetic Stimulation | Change from baseline to final visit. Through study completion, up to 6 weeks. | 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 in Relief Assessed by the Global Assessment of Relief | Change from baseline to final visit. Through study completion, up to 6 weeks. | A 7-point scale indicating overall fecal incontinence symptom relief where 1 represents completely relieved and 7 represents completely worse. |
| Change in Bloating Scale Assessed by a Bloating Scale | Change from baseline to final visit. Through study completion, up to 6 weeks. | A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity. |
| Change in Urgency Assessed by an Urgency Scale | Change from baseline to final visit. Through study completion, up to 6 weeks. | A 10-point scale indicating urgency severity where 0 represents the least severity and 10 represents the most severity |
| Change in Flatus Assessed by a Flatus Scale | Change from baseline to final visit. Through study completion, up to 6 weeks. | A 10-point scale indicating flatus severity where 0 represents the least severity and 10 represents the most severity |
| Change in Waist Circumference Measurement | Change from baseline to final visit. Through study completion, up to 6 weeks. | A measure of the subject's waist circumference in the area where the most bloating is experienced |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKyle Staller, MD MPH
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 68.89 Years STANDARD_DEVIATION 7.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 5 / 31 |
| serious Total, serious adverse events | 1 / 31 |
Outcome results
None listed