Prospective microbiological study on patients with non-constipation IBS treated with rifaximin 550 mg tablets. - ND

ALFA WASSERMA0 个研究点开始时间: 2011年2月3日最近更新: 2013年3月25日

适应症

试验速览

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•Female or male subjects aged = 18 and < 75; Be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions; Female subject currently either of non-childbearing or with a negative pregnancy test both at screening and baseline; not lactating. For Healthy Volunteers: Clinical laboratory tests at screening showing no clinically significant abnormalities and no relevant concomitant diseases in the opinion of the Investigator. For patients with IBS: Non-constipation IBS defined by Rome II criteria.
•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

•Evidence of duodenal ulcer, gastric ulcer, diverticulitis, or infectious gastroenteritis; History of celiac disease, IBD, GI malignancy, GI obstruction, gastroparesis, carcinoid syndrome, pancreatitis, amyloidosis, ileus or cholelithiasis; Diabetes (Type 1 or Type 2); Hyperthyroidism; Lactose intolerance not controlled by lactose free diet; Positive stool culture for pathogenic bacteria, yeast, parasites and viruses; Severe hepatic, renal and cardiac insufficiency; Immunological, haematological or neoplastic disease; Use of any investigational drug within the 3 months prior to screening. For Healthy Volunteers: Subjects with a positive glucose/lactulose breath test; Subject with symptoms related to IBS. For non-C IBS patients: Subject with the symptoms of constipation IBS (Rome II criteria); Subjects with known hypersensitivity to Rifaximin or rifampin or excipients.

发起方

ALFA WASSERMA