Investigation of the efficacy of a novel galacto-oligosaccharide prebiotic (B12GOS) in the treatment of irritable bowel syndrome

Clasado Ltd (UK)0 个研究点目标入组 66 人开始时间: 2005年11月10日最近更新: 2015年1月13日

适应症

试验速览

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•Only patients fulfilling the Rome II criteria for diagnosis of IBS will be included in the study. All will have normal haematological and biochemical indices and no abnormal findings on barium enema or colonoscopy undertaken within the previous five years. Patients will be categorised into diarrhoea predominant (D-IBS), constipation predominant (C-IBS) or altering sub groups of IBS (A-IBS) according to published criteria.

•1. Patients with evidence of organic disease of the gastrointestinal tract such as tumour, inflammatory bowel disease etc. as shown by endoscopic or radiological evaluation of the bowel within the previous 5 years
•2. Patients with abnormal laboratory tests, positive stool cultures in patients with diarrhoea predominant IBS or abnormal proctoscopy or abdominal ultrasound which requires further investigation
•3. Functional disorder of upper gastrointestinal tract for which treatment has not been stable for past three months
•4. Use of other investigational drugs within prior month or intention to use such drugs during the course of the study
•5. Intention to use regularly other medication or investigational agents that affect gastrointestinal motility
•6. Ingestion of products containing pre- and or pro-biotics in the last two weeks before the trial commences
•7. Received antibiotics in the previous three months

发起方

Clasado Ltd (UK)