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Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1)
Bu çalışma, irritabl bağırsak sendromu (irritable bowel syndrome, IBS) olan hastalarda butirat ve palmitoiletanolamid içeren takviyenin (ButirBioma + PeaBioma) etkilerini plaseboya kıyasla incelemektedir. Çalışmaya, Roma IV ölçütlerine göre IBS tanısı almış, 18-70 yaş arası kişiler alınmıştır. Çalışma faz uygulanmayan bir çalışma olarak yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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