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

NCT ID: NCT04806386

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2024-12-11

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.

Conditions

Fecal Incontinence; Irritable Bowel Syndrome With Diarrhea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Psyllium

Intervention Type: DIETARY_SUPPLEMENT

Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.

Interventions

Psyllium

Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyle Staller, MD, MPH

Assistant Professor in Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyle Staller, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2021P000691

Identifier Type: -

Identifier Source: org_study_id