The Role of Fiber in the Prevention and Treatment of Fecal Incontinence
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Stool microbiome
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Kyle Staller, MD, MPH
Assistant Professor in Medicine
Massachusetts General Hospital
Eligibility Criteria
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
- •Informed consent form signed by the subjects
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
- •Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study
- •Inability to tolerate or contraindication to performance of anorectal manometry
- •Celiac disease, Crohn's disease, ulcerative colitis
- •Current anorectal fistula and/or abscess
Outcomes
Primary Outcomes
Stool microbiome
Time Frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Stool samples will be shipped to Metabolon Inc, for metabolomics profiling on a well-validated high-throughput metabolomics platform. Sample prep and global metabolomics profiling will be conducted using four liquid chromatography tandem mass spectrometry methods that measure four complementary sets of metabolite classes. Metabolite peaks are quantified using area-under-the curve. Raw area counts for each metabolite in each sample are normalized to correct for variation resulting from inter-day tuning differences by setting the medians to 1.0 for each run. Metabolites are identified by automated comparison of the ion features in the experimental samples to a reference library of \~8,000 chemical standard entries that are curated for quality control using Metabolon software. Coefficients of variations (CVs) will be measured in blinded quality control samples randomly distributed among study samples, and we will analyze and control for batch variation.
Stool metagenomics
Time Frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Sequence-based microbial community surveys will be carried out to characterize rare taxa and understand relationships between community membership and function from stool samples collected from baseline to the final visit.
Secondary Outcomes
- Fecal Incontinence quality of life (FIQL)(Change from baseline to final visit. Through study completion, up to 6 weeks.)
- Urgency scale(Change from baseline to final visit. Through study completion, up to 6 weeks.)
- Anorectal manometry parameters(Change from baseline to final visit. Through study completion, up to 6 weeks.)
- Waist circumference measurement (cm)(Change from baseline to final visit. Through study completion, up to 6 weeks.)
- Global assessment of relief(Change from baseline to final visit. Through study completion, up to 6 weeks.)
- Bloating scale(Change from baseline to final visit. Through study completion, up to 6 weeks.)
- Flatus scale(Change from baseline to final visit. Through study completion, up to 6 weeks.)
- Fecal incontinence severity index (FISI)(Change from baseline to final visit. Through study completion, up to 6 weeks.)
- Translumbosacral anorectal magnetic stimulation(Change from baseline to final visit. Through study completion, up to 6 weeks.)