UnknownNot Applicable

Feasibility Study of the Proposed Test-and-treat Screening Program in Younger Participants With H. Pylori Infection

Slovenia2,000 participantsStarted 2024-02-01

Plain-language summary

This prospective non-interventional study is being conducted as part of the EU4Health project Eurohelican. The main goal of this pilot study is to evaluate the feasibility and acceptability of implementing the proposed "test-and-treat" screening program on a population-based sample. Participants will be randomly selected from a younger population registered at the primary level of care and tested for the presence of active infection with Helicobacter pylori (H. pylori). Infected participants will undergo a bismuth-based quadruple treatment with antibiotics and a proton pump inhibitor, and will be controlled for eradication success by taking the urea breath test (UBT). A number of other participant outcomes will be also measured to provide additional pro et contra argumentation for the potential future implementation of a population-based test-and-treat screening program in Slovenia. Research reports will be disseminated and results will be presented to the public and scientific community to foster future developments in gastric cancer prevention.

Who can participate

Age range

30 Years – 34 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals aged 30-34 years, * Individuals who have a chosen personal physician at HCM, * Individuals who sign an informed consent to participate, and * Individuals who do not have a congenital or acquired intellectual disability. Exclusion Criteria: * Individuals younger than 30 years or older than 34 years, * Individuals who do not have a chosen personal physician at HCM, * Individuals who do not sign informed consent for participation, * Individuals with intellectual or developmental limitations who are unable to provide a fully-informed consent to participate (based on the assessment of the patient's primary care team) * Individuals who were previously treated for H. pylori infection, and * Individuals with a history of partial of total gastric resection due to benign or malign lesions.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Healthcare workers' assessment of feasibility and acceptability of the proposed practical implementation of a screening program

Timeframe: 1 year after the completion of prospective study.

Trial details

NCT IDNCT06216639

SponsorNational Institute of Public Health, Slovenia

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-12

View on ClinicalTrials.gov More Helicobacter Pylori Infection trials