NCT06216639

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

EU4Health Project Eurohelican: A Single-center Prospective Feasibility Study of the Proposed Test-and-treat Preventive Screening Program in Younger Slovenian Participants Aged 30-34 Years With or Without Helicobacter Pylori Infection

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: National Institute of Public Health, Slovenia · Other Government
• Sex: All
• Age: 30 Years – 34 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Gastric cancer remains an important public health issue due to its high incidence rate and relatively low five-year survival rate. H. pylori infection has been found to be the main cause of gastric cancer and is responsible for 89% of non-cardia gastric cancers. There is also evidence that H. pylori eradication significantly reduces the incidence and mortality due to gastric cancer. According to the proposal based on available data, the population-based test-and-treat screening program may be the best available evidence-based intervention to prevent the occurrence of gastric cancer. In its recommendations from September 9th 2023, the European Council also supported the implementation of a screening program particularly in European regions with an increased prevalence of H. pylori and incidence of gastric cancer. The aim of this study is to scientifically evaluate the feasibility, acceptability and effectiveness of the proposed population-based test-and-treat strategy for the eradication of H. pylori infection. The proposed test-and-treat strategy is targeted at the population around the age of 30 years who are infected with H. pylori and predominantly asymptomatic. The main questions it aims to answer are: * Is the proposed population-based H. pylori test-and-treat strategy feasible and acceptable in a community health service setting? * Is the proposed population-based H. pylori test-and-treat strategy effective in a community health service setting? * What is the profile of adverse events in the treated participants? Participants will be randomly selected from the population pool of individuals aged 30-34 years who have a chosen personal physician at Community Healthcare Center dr. Adolf Drolc Maribor (HCM). Enrolled participants who will give their informed consent will be interviewed by a registered nurse regarding risk factors for developing H. pylori infection and selected lifestyle habits. In addition, serology testing for the presence of H. pylori antibodies will be performed on all participants. Participants with a positive serology result will be given a confirmatory urea breath test (UBT). Those participants with a confirmed active H. pylori infection will be treated with bismuth-based quadruple therapy, and the success of eradication will then be verified by UBT one month after the treatment. Participants with a positive result of the second UBT will be treated again with a second-line modified bismuth-based quadruple therapy, and the success of eradication will be verified by UBT. Compliance with testing and treatment, treatment outcomes, adverse events and reasons for withdrawing participation will be monitored for each of the participants. The feasibility and sustainability of the proposed test-and-treat strategy will be evaluated using several key performance indicators that follow the structure of five principal areas of feasibility. Data will be entered into the REDCap online survey application and analyzed using IBM SPSS Statistics software. The results of this study will enable to potentially scale up the project to the national level and present a potential model for the implementation of this strategy in Europe. Second, the results will contribute to the implementation of the Europe's Beating Cancer Plan goal of preventing gastric cancers caused by H. pylori infections. Finally, this study will provide additional real-world data for the preparation of Expert Working Group Report of the International Agency for Research on Cancer of the World Health Organization (IARC/WHO), which will include a minimum set of standards for the implementation of a population-based screening program at the international level.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Bismuth Subcitrate	Tripotassium dicitratobismuthate 120 mg film-coated tablets. Prescribed for both primary and (potential) secondary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection. The prescribed daily dose is 120 mg QID for a period of 14 days.
DRUG	Esomeprazole	Esomeprazol 40 mg gastro-resistant tablets or hard capsules. Which one of the three brands is prescribed for an individual participant in this prospective study depends on the decision of a chosen personal physician. Prescribed for both primary and (potential) secondary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection. The prescribed daily dose is 40 mg BID for a period of 14 days.
DRUG	Metronidazole	Metronidazol 400 mg tablets. Prescribed for both primary and (potential) secondary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection. The prescribed daily dose is 400 mg QID for a period of 14 days.
DRUG	Amoxicillin	Amoxicillin 500 mg dispersible tablets or hard capsules. Which one of the two brands is prescribed for an individual participant in this prospective study depends on the decision of a chosen personal physician. Prescribed only for the primary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection who are not allergic to penicillin. The prescribed daily dose is 500 mg QID for a period of 14 days.
DRUG	Clarithromycin	Clarithromycin 500 mg film-coated tablets. Prescribed only for the primary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection who are allergic to penicillin. The prescribed daily dose is 500 mg BID for a period of 14 days.
DRUG	Levofloxacin	Levofloxacin 500 mg film-coated tablets. Prescribed only for the (potential) secondary treatment with bismuth-based quadruple therapy in participants with active H. pylori infection. The prescribed daily dose is 500 mg OID for a period of 14 days.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2024-01-22
• Last updated: 2024-02-09

Locations

1 site across 1 country: Slovenia