Prevention of gastric cancer by eradication of Helicobacter pylori infection

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Evaluation of patient-reported outcomes

  Feasibility analysis

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, 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
• Medical condition to be studied:
  Helicobacter infection

Population studied

• Age groups:
  • 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.
• Setting:
  Community Healthcare Center Dr. Adolf Drolc Maribor
• 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).