Principal Investigator Birmingham Region: Prof Richard Hobbs

Locations: ~400 GP practices in Birmingham and Black Country, Worcestershire, Coventry and Warwickshire, Shropshire, Staffordshire, Herefordshire, Stoke, Telford and Wrekin, Wolverhampton, Sussex & Surrey, Nottingham, Durham, Southampton, and Oxford.

Enrolment Period: 2012 – June 2014

Participants: Men and women aged 60+, infected with H. pylori, who are using aspirin <326mg daily

Other Information: This trial has been preceded by a successful pilot study, funded by the MRC. Practices will be reimbursed for their time.

Use of aspirin for cardiovascular prophylaxis is widespread and increasing. The main hazard is ulcer bleeding. This is usually associated with H. pylori infection. It is important to determine whether this can be reduced or prevented by H. pylori eradication. The trial hypothesis is that aspirin does not itself cause peptic ulcers, but that it promotes bleeding of ulcers caused by H. pylori. Given the scale of aspirin use, its continuing increase and its contribution to ulcer bleeding, how to deal with this problem is arguably the most important question with regard to current iatrogenic medicine.

Intervention and Clinic: Suitable patients will be identified by their surgery, using an automated search, and then asked to attend an appointment with a University Research Nurse or Practice Nurse (relevant training will be provided) to consent to the trial and take a H. pylori breath test. Those with a positive result will be randomised to receive a one week course of either eradication treatment or placebo, supplied by the trial centre. No follow-up visits for the patients are required, but any hospital admissions for ulcer bleeding will be recorded over a period of 2-3 years by the trial centre.

Further Information: If you would like to find out more, please contact the Trial Manager for your region, Rachel Iles (r.iles@bham.ac.uk 0121 414 2691).