Efficacy of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR for <i>Helicobacter pylori</i> eradication: a protocol of a multicentre, open, randomised clinical trial.

Abstract

<i>Helicobacter pylori</i> is a major health problem, with the high prevalence of <i>H. pylori</i> and the increasing antibiotic resistance rate in China. Antibiotic resistance is the main reason for the failure of <i>H. pylori</i> eradication. This study aims to evaluate the efficacy and safety of susceptibility-guided quadruple therapy with antibiotic resistance using the string test coupled with quantitative PCR (qPCR) for <i>H. pylori</i> eradication. This is a multicentre, open, randomised clinical trial that will enroll 324 patients with <i>H. pylori</i> infection. Patients will be randomised to two groups for a 14-day treatment: Treatment group will be treated with proton pump inhibitor (PPI), bismuth with two different kinds of antibiotics susceptibly guided by string test coupled with qPCR, while control group will be treated empirically with PPI, bismuth with two different kinds of antibiotics. The types and dosages of bismuth, PPI and antibiotics administered in this trial are based on the 2022 Chinese Guidelines for the treatment of <i>H. pylori</i> infection and the Sixth Chinese National Consensus Report on the management of <i>H. pylori</i> infection. The primary endpoint is the eradication rate, while secondary endpoints include compliance, the incidence of adverse events and adverse drug reactions. This study was approved by the ethics committee of the Third People's Hospital of Zhengzhou (No. 2024-04-001-K02). The results will be published in the appropriate peer-reviewed journal. ChiCTR2400082768.