Reinfection Potential of Helicobacter pylori Pilot Study

Not Applicable

Recruiting

• Conditions: To test the hypothesis that persons can be reinfected with their own strain of H.pylori on multiple occasions; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12607000467437
• Lead Sponsor: Ondek Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-09-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test for positive reinfection using participants' own strain of bacteria. Infection confirmed with C14 UBT 14- 30 days after reinfection. Only one C14 UBT will be done in that time period.[14-30 days after reinfection]

Secondary Outcome Measures

Name	Time	Method
one[N/A]