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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 34
Healthy Volunteers: t
View:

• Young adults (generally 30 - 34 years of age)

Locations
Other Locations
Croatia
Clinical Hospital Center Rijeka
RECRUITING
Rijeka
University Hospital Centre Zagreb
RECRUITING
Zagreb
Ireland
Beacon Hospital
RECRUITING
Dublin
Latvia
Clinical and Preventive Medicine of the University of Latvia
NOT_YET_RECRUITING
Riga
Poland
Wroclaw Medical University
RECRUITING
Wroclaw
Romania
Iuliu Hatieganu University of Medicine and Pharmacy
RECRUITING
Cluj-napoca
Slovenia
National Institute of Public Health, Slovenia
RECRUITING
Ljubljana
Contact Information
Primary
Principal Investigator of the Study - Bojan Tepeš (National Institute of Public Health, Slovenia), Prof., MD
bojan.tepes@siol.net
0038641325916
Backup
Tatjana Kofol Bric (National Institute of Public Health, Slovenia), MD
Tatjana.Kofol@nijz.si
0038612441484
Time Frame
Start Date: 2024-03-04
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 6800
Treatments
Protocol I
H. pylori positive patients who will be treated by bismuth-based quadruple therapy.~Participating centers: KBC Rijeka, Croatia; KBC Zagreb, Croatia; Beacon Hospital, Ireland; Uniwersytet medyczny we Wrocławiu, Poland; UMF Cluj-Napoca, Romania; NIJZ, Slovenia
Protocol II
In case there will be a treatment failure after bismuth-based quadruple therapy, the remaining patients with a positive infection will be referred to a levofloxacin based quadruple therapy.~Participating centers: KBC Rijeka, Croatia; KBC Zagreb, Croatia; Beacon Hospital, Ireland; Uniwersytet medyczny we Wrocławiu, Poland; UMF Cluj-Napoca, Romania; NIJZ, Slovenia
Standard triple therapy
H. pylori positive participants who will offered standard triple therapy.~Participating center: University of Latvia, Latvia
Second line treatment - levofloxacin-based
In case there will be a treatment failure after standart triple therapy, the remaining patients with a positive infection will be referred to a second line treatment~Participating center: University of Latvia, Latvia
Sponsors
Collaborators: Wroclaw Medical University, National Institute of Public Health, Slovenia, Clinical Hospital Center Rijeka, Beacon Hospital, Clinical Hospital Centre Zagreb, Iuliu Hatieganu University of Medicine and Pharmacy
Leads: University of Latvia

This content was sourced from clinicaltrials.gov