None listed
Conditions
Brief summary
The aim of the study is to test the scientific theory that persons can be reinfected with H.pylori on multiple occasions. If so, then a genetically modified H.pylori strain may be the ideal delivery system for live oral vaccines.
Interventions
Healthy participants will be screened for H.pylori infection using Carbon 14 Urea Breath Test (C14 UBT). If infected they will proceed to gastroscopy followed by treatment with the oral antibiotics to eradicate the H.pylori infection. The antibiotics used will be "Nexium HP7"
(containing amoxycillin 1 G twice daily; clarithromycin 500 mg twice daily; esomeprazole 20mg twice daily) for 7 days and "Tinidazole" 500mg twice daily on days 5-7 of the antibiotic treatments. There will be 3 gastroscopi
Healthy participants will be screened for H.pylori infection using Carbon 14 Urea Breath Test (C14 UBT). If infected they will proceed to gastroscopy followed by treatment with the oral antibiotics to eradicate the H.pylori infection. The antibiotics used will be "Nexium HP7" (containing amoxycillin 1 G twice daily; clarithromycin 500 mg twice daily; esomeprazole 20mg twice daily) for 7 days and "Tinidazole" 500mg twice daily on days 5-7 of the antibiotic treatments. There will be 3 gastroscopies and antibiotic treatments and 2 cycles of reinfections done by drinking cultures of their own strain of h.pylori bacteria in a one off drink The reinfection will be done at least 28 days after treatment with antibiotics. The interventions, treatments and reinfections will be done in approximately 3-4 monthly cycles. There is no wash out period.
Sponsors
Ondek Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed