Study of Keverprazan and Amoxicillin Dual Therapy Compared to Rabeprazole Quadruple Therapy for First Treatment of Helicobacter Pylori Infection in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Keverprazan-amoxicillin dual therapy compared to Rabeprazole quadruple therapy for treating Helicobacter pylori infection. This open-label, randomized controlled study plans to enroll 414 adults aged 18 to 65 years who have tested positive for H. pylori and have not received prior eradication therapy. Participants will be randomly assigned to one of three groups to compare different treatment durations and regimens. The study includes three treatment groups one receiving Keverprazan 20 mg twice daily plus Amoxicillin 1 g three times daily for 10 days, another receiving the same dual therapy for 14 days, and a control group receiving Rabeprazole 10 mg, Amoxicillin 1 g, Clarithromycin 500 mg, and colloidal pectin bismuth 200 mg twice daily for 14 days. Participants will be randomized equally into these groups and followed over the course of their assigned treatment. Participants will attend a screening visit to provide consent, medical history, and baseline information, including tests for H. pylori. Follow-up includes a telephone visit during treatment to check vital signs, medication use, and any side effects. A final visit 9 weeks after treatment completion will include physical exams and repeat H. pylori testing to assess eradication. Researchers will monitor adverse events and treatment adherence throughout the study, with the primary goal of measuring H. pylori eradication 6 to 8 weeks after treatment ends.

Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment