Safety and immunogenicity of Helicobacter pylori clinical isolates in healthy volunteers.

Phase 1

Completed

• Conditions: This study will evaluate the safety and immunogenicity of selected Helicobacter Pylori (H.pylori) clinical strains in healthy human volunteers that have not been previously exposed to H. pylori.; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12610000019000
• Lead Sponsor: Ondek Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Inclusion Criteria
1.Healthy men and women
2.Aged 18-70 years inclusive
3.Use their own mobile phone
4.Sero-negative for H. pylori
5.Asymptomatic with regard to dyspepsia. Mild symptomatic but endoscopy negative gastro-oesophageal reflux disease is not an exclusion providing the condition does not require the regular use of Proton Pump Inhibitors or H2 blockers (occasional use permitted). However the participants with the following medical conditions will be excluded:
a.)Peptic Ulcer Disease
b.)History of major gastrointestinal surgery e.g. gastric banding
6.No known allergy to principal medications / antibiotics used to treat
H. pylori in this study (esomeprazole, amoxycillin, clarithromycin and tinidazole). No known intolerances or allergy to 2nd and 3rd line medications /antibiotics used to treat H. pylori, including macrolides, tetracycline, fluoroquinolones, furazolidone, colloidal bismuth subcitrate.
7.Living in Australia for duration of trial (approximately 12 months)
8.Provide written informed consent

Exclusion Criteria

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 contraception 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 will be required to have a negative serum Beta Human Chorionic Gonadotropin (BHCG) pregnancy test before continuing in the study.
2.Current or probable requirement to use any of the following medications: anticoagulants, aspirin, clopidogrel, antibiotics, regular use of proton pump inhibitors (occasional use permitted) or regular use of non steroidal anti-inflammatory drugs (more often than twice weekly).
3.Positive Helicobacter pylori serology at visit 1
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