Evaluating GABA's effect on quality of life in patients with diarrhea-predominant IBS
Evaluation of Quality of Life in a Cohort of Diarrhoeic Irritable Bowel Syndrome (IBS-D) Patients Assuming GABA.
This study is testing if a GABA supplement can improve the quality of life and reduce abdominal discomfort for people with diarrhea-predominant irritable bowel syndrome (IBS-D).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Locations | 2 sites (Pisa and 1 other locations) |
| Trial ID | NCT06755489 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of GABA and a Melissa food supplement on the quality of life and abdominal discomfort in patients diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D). It involves administering either GABA or a placebo to participants aged 18 to 75 who meet the Rome IV criteria for IBS-D. The study will monitor changes in symptoms and overall well-being over the course of the intervention. The rationale behind this approach is to address the visceral pain and discomfort commonly experienced by IBS patients, which significantly affects their daily lives.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of diarrhea-predominant irritable bowel syndrome according to Rome IV criteria.
Not a fit: Patients with constipation-predominant IBS, mixed IBS, or those with significant organic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option for improving the quality of life in patients suffering from diarrhea-predominant IBS.
How similar studies have performed: While the use of GABA in treating IBS is a relatively novel approach, similar studies exploring dietary supplements for IBS have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pisa and 1 other locations
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy (Recruiting)
- University of Pisa — Pisa, Italy (Recruiting)
Study contacts
- Study coordinator: Massimo Bellini, Professor
- Email: massimo.bellini@unipi.it
- Phone: +39 050997415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.