Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a 14-day vonoprazan-based dual therapy compared to two types of quadruple therapy for treating Helicobacter pylori infections. This multicentre, non-inferiority randomized controlled trial aims to determine if the simpler dual therapy is not worse than the more complex quadruple therapies in eradicating the infection. The study focuses on the eradication rate as the primary outcome, with secondary outcomes including side effects and how well patients follow the treatment. Participants receive one of three study treatments over 14 days: the dual therapy with vonoprazan and amoxicillin, or one of two quadruple therapies that add levofloxacin and bismuth or clarithromycin and bismuth to the dual therapy drugs. Doses are specified as vonoprazan 20 mg twice daily and amoxicillin 1000 mg twice daily for all groups, with additional antibiotics and bismuth given once or twice daily depending on the regimen. The study uses single blinding and random assignment to these treatment groups. During the study, participants will be monitored for eradication of Helicobacter pylori six weeks after completing treatment. Researchers will also track adverse events and treatment compliance immediately after the 2-week therapy. The trial includes adults aged 18 to 70 years with confirmed H. pylori infection who have not previously received eradication therapy. Participants are assessed for safety and treatment response through tests and monitoring during and after treatment, with the study expected to conclude by the end of 2026.

Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial