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

NCT04806386 | Completed Results DMC

• 1 other identifier: 2021P000691
• Study Type: interventional
• Target: 31
• 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)

• 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.

  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.

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

Secondary Outcomes (9)

• Change in Fecal Incontinence Severity Assessed by Fecal Incontinence Severity Index (FISI)

  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)

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

• Change in Anal Squeeze Pressure Assessed by Anorectal Manometry

  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

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

• Change in Relief Assessed by the 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
• National Institutes of Health (NIH): collaborator

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

Results Point of Contact

• Title: Kyle Staller
• Organization: Massachusetts General Hospital

kstaller@mgh.harvard.edu

6177262000

Study Officials

• Kyle Staller, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)