The Role of Fiber in the Prevention and Treatment of Fecal Incontinence

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 permonth

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-inperiod

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 wouldimpair 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 theprevious 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

18. History of intestinal stricture (e.g., Crohn's disease) 20. History of intestinalobstruction or subjects at high risk of intestinal obstruction including suspectedsmall bowel adhesions 21. History of malabsorption 22. Any other clinicallysignificant disease interfering with the assessments of psyllium, according to theInvestigator (e.g., disease requiring corrective treatment, potentially leading tostudy discontinuation) 23. Any relevant biochemical abnormality interfering with theassessments of psyllium, according to the Investigator 24. Patients with metallicimplants within a 30 cm radius of the TAMS electromagnetic coil 25. Currently onopioids 26. Patients with severe cardiac disease, chronic renal failure, or previousGI surgery EXCEPT cholecystectomy, appendectomy, Nissen fundoplication, and partialcolectomy 27. Patients with neurological diseases and increased intracranialpressure 28. Patients with impaired cognizance 29. Previous pelvicsurgery/radiation, radical hysterectomy 30. Patients with Ulcerative Colitis orCrohn's Disease 31. History of or current rectal prolapse 32. Previous history ofanal fissure, anal surgery (abscess), congenital anorectal malformation, fistulae orinflamed hemorrhoids 33. Pregnant women 34. Use of antibiotics in previous 60 days