Study type

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Bizmutov oksid Krka 120 mg film-coated tablets, Emozul 40 mg hard gastroresistant capsules, Nexium 40 mg gastroresistant tablets, Nillar 40 mg gastroresistant tablets, Efloran 400 mg tablets, Tavanic 500 mg film-coated tablets, Fromilid 500 mg film-coated tablets, Amoksicilin Belupo 500 mg dispersible tablets, Hiconcil 500 mg hard capsules
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)

Estimated number of subjects

2000
Study design details

Main study objective

The main objective of this observational study is to assess the feasibility of implementing the proposed "test-and-treat" screening program.

Outcomes

1.Feasibility and acceptability of the proposed practical implementation of a screening program. 2. Participation rate of patients invited into the program, 3. Eradication rate of infection with H. pylori, 4. Description of adverse events profile, 5. Associations between patient-reported outcomes and the results of test-and-treat strategy.

Data analysis plan

Analytical methods will depend on the type of research question: 1.Feasibility and acceptability of the proposed practical implementation of a screening program: qualitative questionnaire following the structure of TELOS framework. 2.Participation rate of patients invited into the program: descriptive calculation of rates. 3. Eradication rate of infection with H. pylori: descriptive calculation of rates. 4. Adverse events profile: qualitative (and descriptive) analysis. 5. Associations between patient-reported outcomes and the results of test-and-treat strategy: correlation analysis, chi-square test, odds ratio (or relative risk).