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

NCT04806386 | Completed DMC

• 1 other identifier: 2021P000691
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.)

Conditions

Fecal Incontinence; Irritable Bowel Syndrome With Diarrhea

Keywords

IBS-D; IBS; FI; Fecal Incontinence; Irritable Bowel Syndrome with Diarrhea; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change from baseline to final visit. Through study completion, up to 6 weeks.

Secondary Outcomes (9)

• Fecal incontinence severity index (FISI)

  Change from baseline to final visit. Through study completion, up to 6 weeks.

• Fecal Incontinence quality of life (FIQL)

  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.

• Translumbosacral anorectal magnetic stimulation

  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.

Study Arms (1)

Psyllium fiber supplement treatment

EXPERIMENTAL

All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.

Dietary Supplement: Psyllium

Interventions

Psyllium DIETARY_SUPPLEMENT

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

Psyllium fiber supplement treatment

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Age \<50 or \>90
• BMI of \<18.5 or ≥40 kg/m2
• History of allergic reaction to psyllium
• Previous trial of soluble fiber supplementation for fecal incontinence within the previous 30 days
• History of sacral nerve stimulator or artificial anal sphincter placement

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Fecal Incontinence; Irritable Bowel Syndrome

Interventions

Psyllium

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases, Functional; Colonic Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Kyle Staller, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Medicine

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 19, 2021
• Study Start: July 21, 2021
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: May 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)