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Could a fiber bar fix leaky gut? new study investigates

NCT ID NCT04806386

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether psyllium fiber bars can help postmenopausal women with irritable bowel syndrome and diarrhea who experience accidental bowel leakage. Researchers will examine changes in gut bacteria and stool chemicals to see if fiber improves symptoms. The study involves 31 women aged 50 to 90.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
psyllium fiber
What this could lead to
If it works, this could point toward a simple dietary supplement to help manage fecal incontinence in postmenopausal women.
What could go wrong
This is a small, early-stage study with only 31 participants, so results may not apply to everyone. The fiber supplement may not improve symptoms or could cause digestive discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

31 people

The number who actually took part.

Started

Jul 2021

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 90 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female, post-menopausal 2. Age 50-90 years old 3. BMI \>18.5 and \<40 kg/m2 4. Rome IV criteria for liquid stool fecal incontinence occurring at least twice per month 5. At least one FI episode during the run-in period 6. Compliant with reporting during run-in (completion of two 3-day food diaries and two 7-day bowel diaries) 7. Submission of two stool samples during the run-in period 8. Ability to follow verbal and written instructions 9. Informed consent form signed by the subjects Exclusion Criteria: 1. Less than two episodes per month of liquid stool fecal incontinence 2. Non-compliance with reporting during run-in 3. Patients reporting laxative, enema, and/or suppository usage during the run-in period 4. GI tract structural abnormality that would increase likelihood of obstruction 5. Dysphagia, swallowing disorder, or history of esophageal structural lesions 6. History of GI lumen surgery within 60 days prior to entry into the study 7. Neurological disorders, metabolic disorders, or other significant disease that would impair their ability to participate in the study 8. Inability to tolerate or contraindication to performance of anorectal manometry 9. Celiac disease, Crohn's disease, ulcerative colitis 10. Current anorectal fistula and/or abscess 11. Age \<50 or \>90 12. BMI of \<18.5 or ≥40 kg/m2 13. History of allergic reaction to psyllium 14. Previous trial of soluble fiber supplementation for fecal incontinence within the previous 30 days 15. History of sacral nerve stimulator or artificial anal sphincter placement 16. Administration of investigational products within 1 month prior to Screening Visit 17. Subjects anticipating surgical intervention during the study 19\. History of intestinal stricture (e.g., Crohn's disease) 20. History of intestinal obstruction or subjects at high risk of intestinal obstruction including suspected small bowel adhesions 21. History of malabsorption 22. Any other clinically significant disease interfering with the assessments of psyllium, according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation) 23. Any relevant biochemical abnormality interfering with the assessments of psyllium, according to the Investigator 24. Patients with metallic implants within a 30 cm radius of the TAMS electromagnetic coil 25. Currently on opioids 26. Patients with severe cardiac disease, chronic renal failure, or previous GI surgery EXCEPT cholecystectomy, appendectomy, Nissen fundoplication, and partial colectomy 27. Patients with neurological diseases and increased intracranial pressure 28. Patients with impaired cognizance 29. Previous pelvic surgery/radiation, radical hysterectomy 30. Patients with Ulcerative Colitis or Crohn's Disease 31. History of or current rectal prolapse 32. Previous history of anal fissure, anal surgery (abscess), congenital anorectal malformation, fistulae or inflamed hemorrhoids 33. Pregnant women 34. Use of antibiotics in previous 60 days

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence irritable bowel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.