The Role of Fiber in the Prevention and Treatment of Fecal Incontinence (NCT04806386) | Clinical Trial Compass
CompletedNot Applicable
The Role of Fiber in the Prevention and Treatment of Fecal Incontinence
United States35 participantsStarted 2021-07-21
Plain-language 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.)
Who can participate
Age range50 Years – 90 Years
SexFEMALE
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Inclusion criteria
✓. Female, post-menopausal
✓. Age 50-90 years old
✓. BMI \>18.5 and \<40 kg/m2
✓. Rome IV criteria for liquid stool fecal incontinence occurring at least twice per month
✓. At least one FI episode during the run-in period
✓. Compliant with reporting during run-in (completion of two 3-day food diaries and two 7-day bowel diaries)
✓. Submission of two stool samples during the run-in period
✓. Ability to follow verbal and written instructions
Exclusion criteria
✕. Less than two episodes per month of liquid stool fecal incontinence
✕. Non-compliance with reporting during run-in
✕. Patients reporting laxative, enema, and/or suppository usage during the run-in period
✕. GI tract structural abnormality that would increase likelihood of obstruction
✕. Dysphagia, swallowing disorder, or history of esophageal structural lesions
✕. History of GI lumen surgery within 60 days prior to entry into the study
What they're measuring
1
Stool metagenomics
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.
2
Stool microbiome
Timeframe: Change from baseline to final visit. Through study completion, up to 6 weeks.