H. Pylori Screen-and-treat Study in a Population of Young Adults

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-34
SponsorUniversity of Latvia

About this trial

Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia.

Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up.

Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention.

Eligibility criteria

Qualifiers

Young adults (generally 30 - 34 years of age)

Disqualifiers

Patients with mental or developmental limitations who cannot provide a fully-informed consent to participate (based on the assessment from research or patient's personal physician team)

Previously treated H. pylori infection

History of partial or total gastric resection due to benign or malign lesions

Trial design

Treatments tested in this trial

  • Bismuth-based quadruple therapy
  • Levofloxacin-based quadruple therapy
  • Standard triple therapy
  • Levofloxacin-based triple

Treatment groups

6,800 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Latvia

Lead sponsor

Clinical Hospital Center Rijeka

Collaborator

Clinical Hospital Centre Zagreb

Collaborator

Beacon Hospital

Collaborator

Wroclaw Medical University

Collaborator

Iuliu Hatieganu University of Medicine and Pharmacy

Collaborator

National Institute of Public Health, Slovenia

Collaborator