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GABA supplement shows promise for IBS-Related discomfort

NCT ID NCT06755489

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a food supplement containing GABA and Melissa can help improve quality of life and reduce belly discomfort in people with diarrhea-predominant irritable bowel syndrome (IBS-D). Twenty adults with IBS-D took the supplement, and researchers measured changes in quality of life, abdominal discomfort, anxiety, and depression. The goal was to see if this natural supplement could ease symptoms and improve daily well-being.

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

20 people

The number who actually took part.

Started

Apr 2023

Finished

Mar 2025

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

18 to 75 years

Sex

Anyone

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: * Age \> 18 years and ≤ 75 * A positive diagnosis of IBS-D according to Rome IV criteria. * Both males and females. * Negative relevant additional screening or consultation whenever appropriate * Colonoscopy if there are alarm symptoms (eg. Rectal bleeding, pseudodiarrhea). If the patients' age is \> or = 50 yrs a colonoscopy within 5 years is mandatory. * Availability to participate in the clinical study, confirmed by the signed informed consent form. * Ability to conform to the study protocol. * Patients' ability to complain study protocol procedures. * Subjects who decide to use single or double contraceptive methods not to conceive during study period. Exclusion Criteria: * Patients with IBS-C, IBS-M and IBS-U according to Rome IV criteria. * Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant. * Ascertained intestinal organic diseases, including celiac disease, food allergies or inflammatory bowel diseases (Crohn's disease, ulcerative colitis, diverticular disease, infectious colitis, ischemic colitis, microscopic colitis). * Previous major abdominal surgery. * Active malignancy of any type, or history of a malignancy (patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years before study enrolment are also acceptable). * Use of -pre or probiotics, topical and/or systemic antibiotic and prokinetic therapy during the 15 days before treatment starts. * Systematic/frequent use of contact laxatives. * Pregnant or breastfeeding woman. * Females of childbearing potential in the absence of effective contraceptive methods. * Inability to conform to protocol. * Treatment with any investigational drug within the previous 30 days. * Recent history or suspicion of alcohol abuse or drug addiction. * Presence of red or white flags at the Rome IV Psychosocial Alarm Questionnaire for Functional gastrointestinal Disorders

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124, Italy

  • University of Pisa

    Pisa, 56126, Italy