Randomised controlled trial of metronidazole and probiotic preparation versus placebo in the treatment of irritable bowel syndrome - Probiotic in IBS

Yakult Honsha Co0 个研究点目标入组 120 人开始时间: 2005年5月26日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•Age over 18.
•Clinical diagnosis of IBS fulfilling Rome II criteria (see appendix)
•Normal FBC, U&E, LFT, and inflammatory markers within preceding 2 weeks
•Appropriate –ve investigations for organic disease. Patients under 45 do not have to undergo endoscopic or radiological bowel investigation. Patients over the age of 45 with developing symptoms must undergo colonoscopy or barium enema (within last 5 years) to exclude cancer, obstruction, or other structural disease.
•Ability to give written informed consent agreeing to participation in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Breast Feeding
•Inability to give informed consent
•Inability to comply with trial protocol
•Inflammatory bowel disease or other organic disease of the GI tract
•Significant co-morbidity likely to compromise the patient’s ability to comply with the study
•Inability to withdraw other medications given for treatment of IBS
•Use of other investigational drugs or participation in other clinical trial
•Alcoholism / Drug abuse

发起方