IDDF2019-ABS-0144 Efficacy of 7-day vonoprazan and amoxicillin dual therapy as first-line helicobacter pylori treatment: protocol of multi-center, non-inferiority, randomized control trial

Abstract

Background Recent international guidelines recommend four-drug combination therapies as first-line treatment to overcome Helicobacter pylori antibiotic resistance and achieve sufficient eradication rates. However, these regimens have the drawbacks of severe side effects, high cost, and low compliance due to the use of multiple antibiotic agents. Furthermore, usage of multiple antibiotic agents in H. pylori treatment have some concern to increase future its antibiotic resistance. Thus, novel regimens that enable minimum antibiotic use, prevent future antibiotic resistance, and achieve sufficient eradication rates, are required. Vonoprazan and amoxicillin dual therapy could be an alternative treatment regimen for H. pylori eradication. This study aimed to investigate the efficacy of vonoprazan-based dual therapy as first-line H. pylori treatment compared with vonoprazan-based triple therapy. Methods This study will enroll 320 patients with H. pylori infection, confirmed by culture test, at seven institutions in Japan. The enrolled patients will be randomly assigned to either VA-dual therapy (vonoprazan 20 mg + amoxicillin 750 mg twice/day for 7 days) or VAC-triple therapy (vonoprazan 20 mg + amoxicillin 750 mg + clarithromycin 200 mg twice/day for 7 days) at a 1:1 allocation ratio with stratification by age, sex, amoxicillin resistance of H. pylori, clarithromycin resistance of H. pylori, and institution. The primary outcome of this study is H. pylori eradication rates in both groups. Eradication success is evaluated at least 4 weeks after the treatment period using the 13C-urea breath test. Comparative non-inferiority of the two groups will be assessed through a derivation of a two-sided 95% confidence interval (CI) and hypothesis testing. The secondary endpoints are adverse events rates. Results This study was approved by the Institutional Review Board of Nihon University School Hospital on September 18, 2018. The recruitment started from October 2018 and will continue for an 8-month period. Conclusions The findings of this study will be submitted to a peer-reviewed journal. Abstracts will be submitted to relevant national and international conferences. This study is registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (www.umin.ac.jp/ctr/; identification No.: UMI3414).