7-day High-Dose Vonoprazan-amoxicillin Dual Therapy Versus 14-day Vonoprazan-amoxicillin Dual Therapy for H. Pylori

Efficacy and Safety of Short-Term, High-Dose Vonoprazan-Based Dual Therapy Versus Standard-Dose Vonoprazan-Based Dual Therapy for Helicobacter Pylori Eradication: A Multicenter, Open-Label, Randomized Controlled Trial

Helicobacter pylori infection is a prevalent global gastrointestinal condition linked to chronic gastritis, peptic ulcer disease, and gastric cancer. Potent and sustained acid suppression improves eradication efficacy. Vonoprazan, a potassium-competitive acid blocker, provides rapid and stable acid inhibition and has become an important component of dual therapy with amoxicillin. However, the optimal dosing strategy and treatment duration for vonoprazan-based dual therapy are not yet fully established.

This multicenter, open-label, randomized controlled trial compares the efficacy and safety of a short-term, high-dose vonoprazan-based dual therapy (20 mg three times daily for 7 days) with a standard-dose regimen (20 mg twice daily for 14 days), both combined with amoxicillin, for first-line H. pylori eradication. Adult participants with confirmed H. pylori infection will be randomized 1:1 to the two treatment groups. The primary outcome is the eradication rate of H. pylori at 6 weeks after completion of therapy. Secondary outcomes include safety assessments and medication adherence. This study will provide evidence on whether a higher dose and shorter treatment course can achieve similar eradication rates with acceptable safety and tolerability compared to the standard regimen.

Inclusion Criteria:

• Age 18-70 years, no gender restrictions;
• Patients with H. pylori infection confirmed by 13C/14C-urea breath test ;
• No prior history of H. pylori eradication therapy;

Exclusion Criteria:

• Patients allergic to study medications (vonoprazan fumarate, amoxicillin);
• Patients with active qastrointestinal bleeding,;
• Patients undergone or scheduled to undergo surgery within 1 month prior to randomization or during the study period that may affect gastric acid secretion (e.g., gastric surgery, vagotomy, or craniotomy);
• Patients underlying severe medical conditions deemed by the investigator to potentially confound study results or compromise subject safety, such as: hepatic impairment (ALT or AST > 1.5 times the upper limit of normal); renal impairment (Cr ≥ 2.0 mg/dL or eGFR < 50 mL/min/1.73 m²); immunosuppression; malignancy; severe central nervous system, cardiovascular, or respiratory disease;
• Patients with medication history of bismuth, antibiotics within 4 weeks, or proton pump inhibitors within 2 weeks;
• Patients with behaviors potentially increasing disease risk: history of chronic substance abuse or alcohol dependence within 12 months prior to screening;
• Patients planning pregnancy, currently pregnant, breastfeeding, or unwilling to use contraception during the trial period;
• Patients unable or unwilling to provide informed consent.