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.)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
Massachusetts General Hospital
Boston, Massachusetts, United States
Stool metagenomics
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.
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Stool microbiome
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.
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Fecal incontinence severity index (FISI)
Questionnaire about the severity of symptoms in those with fecal incontinence. Consists of 4 questions, each rated on a scale of 1 to 6. Lower scores indicate higher severity of symptoms. (Min, 4, max 24)
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Fecal Incontinence quality of life (FIQL)
Questionnaire about the quality of life of those with fecal incontinence. Questions are rated from 1 to 4 in each section. Lower rating represent worse quality of life. Subscales exist for lifestyle, coping behavior, embarrassment, and depression. There is no total score for this outcome, only subscores per section. (Min 4, max, 16)
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Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Anorectal manometry parameters
Anorectal manometry (ARM) procedure performed to measure the change in anal and rectal muscle function and sensation at baseline and at the final visit.
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Translumbosacral anorectal magnetic stimulation
Translumbosacral anorectal magnetic stimulation (TAMS) performed during the ARM procedure to measure the change in the nerve conduction between the spinal cord and rectum at baseline and at the final visit.
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Global assessment of relief
A 7-point scale indicating overall fecal incontinence symptom relief where 1 represents completely relieved and 7 represents completely worse.
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Bloating scale
A 10-point scale indicating bloating severity where 0 represents the least severity and 10 represents the most severity
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Urgency scale
A 10-point scale indicating urgency severity where 0 represents the least severity and 10 represents the most severity
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Flatus scale
A 10-point scale indicating flatus severity where 0 represents the least severity and 10 represents the most severity
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Waist circumference measurement (cm)
A measure of the subject's waist circumference in the area where the most bloating is experienced
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.