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
31
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
Change in Stool Metagenomics Assessed by Sequence-based Microbial Communities and Rare Taxa
The Shannon Diversity Index is a measure of within-sample microbial diversity that incorporates both the number of microbial taxa present (i.e., richness) and the distribution of their relative abundances (i.e., evenness). It is calculated using the relative abundance of observed taxa within each stool sample. Higher values indicate greater microbial diversity. The theoretical minimum value is 0, and there is no fixed theoretical maximum because the upper bound depends on the number of taxa detected in a sample and sequencing depth. In human gut microbiome studies, observed values commonly range from approximately 2 to 6.
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Stool Butyrate Abundance Measured by Untargeted LC-MS Metabolomics
Butyrate was measured in stool samples using untargeted LC-MS metabolomics performed by Metabolon. Values were batch-normalized by dividing each sample value by the batch-specific median for butyrate, and missing values were imputed using the minimum observed value across batches. The resulting values were log-transformed before analysis. Higher values indicate greater relative abundance of butyrate in stool. Because this measure reflects relative abundance rather than absolute concentration, there is no fixed theoretical range.
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Fecal Incontinence Severity Assessed by 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.
Change in Fecal Incontinence Quality of Life Assessed by Fecal Incontinence Quality of Life (FIQL)
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Questionnaire about the quality of life of those with fecal incontinence. Questions are rated from 1 to 4 in each of 4 sections. Lower rating represent worse quality of life and higher scores represent higher quality of life. (Min 4, max, 16)
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Anal Squeeze Pressure Assessed by Anorectal Manometry
Squeeze pressure assessed using a pressure sensory for Anorectal manometry (ARM) procedure performed to measure anal and rectal muscle function and sensation.
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Lumbo and Sacral Nerve Latency Assessed by 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.
Time frame: Change from baseline to final visit. Through study completion, up to 6 weeks.
Change in Relief Assessed by the 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.
Change in Bloating Scale Assessed by a 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.
Change in Urgency Assessed by an 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.
Change in Flatus Assessed by a 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.
Change in Waist Circumference Measurement
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.