Quality of Life in Diarrhea-predominant Irritable Bowel Syndrome Taking GABA

Who can take part

• 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

Who cannot take part

• Previous major abdominal surgery
• Use of -pre or probiotics, topical and/or systemic antibiotic and prokinetic therapy during the 15 days before treatment starts
• Treatment with any investigational drug within the previous 30 days
• Recent history or suspicion of alcohol abuse or drug addiction
• 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)
• 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)
• Presence of red or white flags at the Rome IV Psychosocial Alarm Questionnaire for Functional gastrointestinal Disorders
• 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
• Patients with IBS-C, IBS-M and IBS-U according to Rome IV criteria
• 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