This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based dual therapy ( triple therapy) versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication. Furthermore, the investigators will investigate the impact of these eradication regimens on the gut microbiota, the development of antibiotic resistance, and changes in metabolic syndrome indicators pre- and post-treatment.
Individuals infected with Helicobacter pylori who have not previously undergone eradication therapy.
Individuals willing to receive first-line eradication therapy.
Study participants must be 20 years of age or older.
Individuals with a history of gastrectomy (stomach removal surgery).
Individuals unsuitable to receive the study drug (e.g., history of allergy or severe adverse effects to the study drug).
Pregnant or breastfeeding women.
Individuals with severe acute or chronic diseases, such as renal failure, liver cirrhosis, or incurable malignant tumors.
Parallel
Bismuth Add-on to Vonoprazan Dual Therapy
Drugbismuth, vonoprazan and amoxicillin for 14 days
Vonoprazan dual therapy
Drugvonoprazan and amoxicillin for 14 days
Eradication rate determined by Intention-to-Treat (ITT) analysis
Eradication rate will be determined by urea breath test at least 6 weeks later after completion of treatment.
Per-protocol (PP) eradication rate; adverse event profiles
Eradication rate will be determined by urea breath test at least 6 weeks later after completion of treatment. A standard interview and questionaire will be used toassess the adverse effects.
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