GABA supplement shows promise for IBS-Related discomfort
NCT ID NCT06755489
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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20 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Mar 2025
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Azienda Ospedaliero Universitaria Pisana
Pisa, 56124, Italy
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University of Pisa
Pisa, 56126, Italy