NCT04806386

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2021-07-21
• Primary completion: 2024-12-11
• Completion: 2024-12-11
• First posted: 2021-03-19
• Last updated: 2025-05-13

Locations

1 site across 1 country: United States