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This study examines the effects of a supplement containing butyrate and palmitoylethanolamide (ButirBioma + PeaBioma) compared with placebo in patients with irritable bowel syndrome (IBS). It included people aged 18-70 diagnosed with IBS according to Rome IV criteria. It was run as a study with no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * ● IBS patients (both males and females) with positive diagnosis based on Rome IV criteria (IBS-D and IBS-M) * Age in the range 18-70 years * Subjects capable of conforming to the study protocol * Subjects who have given their free and informed consent Exclusion Criteria: -Any relevant organic, systemic or metabolic disease, including celiac disease, IDDM (Insulin- Dependant Diabetes Mellitus), Insulin-Independent Diabetes Mellitus, metabolic syndrome, pelvic organ prolapses, urinary incontinence, ulcerative colitis, Crohn's disease, microscopic colitis, infectious colitis, ischemic colitis, complicated diverticular disease. * Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food * Prior major gastrointestinal surgeries * Females of childbearing potential, in the absence of effective contraceptive methods * Subjects who become unable to conform to protocol * Subjects who are continuously taking contact laxatives * Subjects who are treated continuously with glucocorticoids, anti-histaminergic and mast cell stabilizer drugs * Subjects who are treated continuously with trimebutine * Recent history or suspicion of alcohol abuse or drug addiction * Subjects who are treated with antibiotics or probiotics