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Dietary Supplement

Psyllium for Bowel Incontinence

N/A
Recruiting
Led By Kyle Staller, MD MPH
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female, post-menopausal
Age 55-85 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to final visit. through study completion, up to 6 weeks.
Awards & highlights

Study Summary

This trial is testing whether fiber supplements can help improve symptoms and anorectal physiology in post-menopausal women with irritable bowel syndrome who have diarrhea and liquid stool fecal incontinence.

Who is the study for?
This trial is for post-menopausal women aged 55-85 with irritable bowel syndrome and diarrhea who experience fecal incontinence at least twice a month. They must be able to follow instructions, complete food and bowel diaries, submit stool samples, have a BMI between 18.5 and 40, and not have had certain GI surgeries or conditions.Check my eligibility
What is being tested?
The study tests the effects of psyllium fiber supplementation on digestive health in participants. It aims to see if this fiber can help manage symptoms related to fecal incontinence by examining changes in gut bacteria and waste products.See study design
What are the potential side effects?
While not explicitly stated, common side effects of psyllium may include bloating, gas, stomach cramping, or an allergic reaction for those sensitive to it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman and have gone through menopause.
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I am between 55 and 85 years old.
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I am between 50 and 90 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to final visit. through study completion, up to 6 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to final visit. through study completion, up to 6 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stool metagenomics
Human Microbiome
Secondary outcome measures
Anorectal manometry parameters
Bloating scale
Fecal Incontinence quality of life (FIQL)
+6 more

Side effects data

From 2017 Phase 2 trial • 54 Patients • NCT03198767
83%
Diarrhea
25%
Constipation
4%
Decreased appetite
4%
Abdominal discomfort
4%
Abdominal pain
4%
Abdominal pain lower
4%
Flatulence
4%
Nausea
4%
Back pain
4%
Abdominal distension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: LIK066 + 50% CHO
Part A: LIK066 + 25% CHO
Part A: LIK066 + 0% CHO
Part A: LIK066 + 8% CHO
Part B: LIK066 + 50% CHO + NS
Part B: LIK066 + 50% CHO + PS
Part B: LIK066 + 50% CHO CC

Trial Design

1Treatment groups
Experimental Treatment
Group I: Psyllium fiber supplement treatmentExperimental Treatment1 Intervention
All patients will receive psyllium fiber in the form of edible bars, 7g, twice a day to total 14g per day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psyllium
2015
Completed Phase 4
~720

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,460 Total Patients Enrolled
Kyle Staller, MD MPH3.79 ReviewsPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital
1 Previous Clinical Trials
500 Total Patients Enrolled
5Patient Review
I had a great experience at Danvers mass general when I had to go through a colonoscopy. I would highly recommend it.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any available slots for this research trial?

"In accordance with the details at clinicaltrials.gov, this research is recruiting participants. The protocol was released on July 21st 2021 and last revised on March 1st 2022."

Answered by AI

Is it possible for me to join in the clinical experiment?

"This medical trial seeks 30 individuals above the age of 55 and below 85 who suffer from fecal soiling. Eligible candidates must be female, post-menopausal, have a BMI between 18.5 - 40 kg/m2, experience at least one FI episode in the run-in period, understand written and verbal instructions provided by researchers, sign an informed consent document prior to participating in this study as well as meeting Rome IV criteria for liquid stool fecal incontinence occurring twice per month or more. Additionally, these participants are asked to complete two 3-day food diaries and two 7-day bowel diaries during the"

Answered by AI

How many volunteers are enrolled in this research project?

"Indeed, the information on clincialtrials.gov affirms that this clinical trial is currently seeking participants. This investigation was originally advertised on July 21st 2021 and its most recent update happened March 1st 2022. 30 test subjects need to be sourced from a single medical facility."

Answered by AI

What are the aims of this medical experiment?

"This research is assessing the efficacy of stool metagenomics over a 6-week period. Secondary outcomes to be tracked include global assessment of relief (7-point scale from completely relieved to worse), translumbosacral anorectal magnetic stimulation (measuring changes in nerve conduction between spine and rectum) and bloating severity rating (10-point scale ranging from least severe to most)."

Answered by AI

Does this research project admit applicants who have not reached the age of 25?

"This clinical trial requires that applicants be between the ages of 55 and 85. There are 411 medical studies available for participants under 18 years old, while 1062 trials exist for those above 65."

Answered by AI

Who else is applying?

What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
The Role of Fiber in the Prevention and Treatment of Fecal Incontinence
Kyle Staller, MD, MPH 2021. "The Role of Fiber in the Prevention and Treatment of Fecal Incontinence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04806386.
All > Irritable Bowel Syndrome > Ibs
~4 spots leftby Oct 2024
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