Reinfection Potential of Helicobacter pylori Pilot Study

Ondek Pty Ltd0 个研究点目标入组 5 人开始时间: 2007年9月18日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.Healthy men /women
•2.Aged 18-65 inclusive
•3.No known allergy to principal medication/antibiotics used to treat H.pylori in this study
•No known intolerances or allergy to 2nd and 3rd line medication/antibiotics used to treat H.pylori, including macrolites, tetracycline, fluoroquinolones, furazolidone, colloidal bismuth subcitrate
•4. Living in Australia for duration of trial (approximately 12-18 months)
•5. Speaks English
•6. Minimum high school education
•7. Priority given to volunteers who own a mobile phone
•8. Provide informed consent

•1. Pregnant or breast feeding women; women who are less than 2 years postmenopausal; or women of child bearing potential not using adequate contraception for the duration of the study (adequate ccontraception is the use of oral contraceptives, contraceptive injections, intra-uterine device, contraceptive patches, or the use of a double barrier contraception method (e.g. use of condom and spermicidal cream simultaneously) Women of child bearing potential can safely take the 1st screening PYtest C14 UBT at visit 1, but will be required to have a negative serum Beta Human Chorionic Gonadatrophin pregnancy test before continuing in the study
•2. History of recurrent infections requiring treatment with antibiotics
•3. Current or probable requirement to use any of the following medications: anticoagulants, aspirin, antibiotics, proton pump inhibitors or regular use of non steroidal anti-inflammatory drugs( more than twice weekly)
•4. Current enrolment in another clinical trial involving a medication or device
•5. Living with or having daily contact with children aged 12 years or younger at home, school, day care or equivalent facilities

发起方