Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000467437
Ethics application status
Approved
Date submitted
11/09/2007
Date registered
18/09/2007
Date last updated
29/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Reinfection Potential of Helicobacter pylori Pilot Study
Scientific title
Reinfection Potential of Helicobacter pylori Pilot Study
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To test the hypothesis that persons can be reinfected with their own strain of H.pylori on multiple occasions 2356 0
Condition category
Condition code
Oral and Gastrointestinal 2460 2460 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2076 0
Other interventions
Comparator / control treatment
uncontrolled group. All participants will undergo all treatments and interventions
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3360 0
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.
Timepoint [1] 3360 0
14-30 days after reinfection
Secondary outcome [1] 5577 0
None
Timepoint [1] 5577 0
N/A

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 427 0
6009

Funding & Sponsors
Funding source category [1] 2610 0
Commercial sector/Industry
Name [1] 2610 0
Ondek Pty Ltd
Country [1] 2610 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ondek Pty Ltd
Address
Locked Bag 15
Subiaco WA 6904
Country
Australia
Secondary sponsor category [1] 2360 0
None
Name [1] 2360 0
Address [1] 2360 0
Country [1] 2360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4530 0
Sir Charles Gairdner Hospital Human Research Ethics Committee
Ethics committee address [1] 4530 0
E Block
Hospital Avenue
Nedlands WA 6009
Ethics committee country [1] 4530 0
Australia
Date submitted for ethics approval [1] 4530 0
01/05/2007
Approval date [1] 4530 0
21/08/2007
Ethics approval number [1] 4530 0
2007-045

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28044 0
Address 28044 0
Country 28044 0
Phone 28044 0
Fax 28044 0
Email 28044 0
Contact person for public queries
Name 11201 0
Ros Stott
Address 11201 0
Sir Charles Gairdner Hospital
Department of Gastroenterology, G75
Hospital Avenue
Nedlands WA 6009
Country 11201 0
Australia
Phone 11201 0
08 9346 4036
Fax 11201 0
08 9346 3207
Email 11201 0
[email protected]
Contact person for scientific queries
Name 2129 0
Barry J Marshall
Address 2129 0
Sir Charles Gairdner Hospital
Department of Gastroenterology, G75
Hospital Avenue
Nedlands WA 6009
Country 2129 0
Australia
Phone 2129 0
08 9346 4815
Fax 2129 0
08 9346 4816
Email 2129 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHelicobacter pylori overcomes natural immunity in repeated infections.2016https://dx.doi.org/10.1002/ccr3.687
N.B. These documents automatically identified may not have been verified by the study sponsor.