Efficacy of quadruple regimen with polaprezinc for gastric <i>Helicobacter pylori</i> infection eradication: protocol for a single-centre, single-blind, non-inferiority, randomised clinical trial.

Abstract

<i>Helicobacter pylori (H. pylori)</i> is the most well-known risk factor for gastric cancer. At present, <i>H. pylori</i> shows varying levels of resistance to different treatments, leading to a lower rate of <i>H. pylori</i> eradication. The aim of this study is to evaluate the efficacy of polaprezinc-containing quadruple therapy (PQT) for the eradication of <i>H. pylori</i> infection and, thus, to provide more evidence to inform the clinical treatment of <i>H. pylori</i> infection in China. This is a single-centre, single-blind, non-inferiority, randomised controlled trial, enrolling 158 patients with <i>H. pylori</i> infection. Patients are randomised (1:1) to the two groups for a 14-day therapy. Treatment group: PQT (esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, polaprezinc 75 mg) two times per day; control group: bismuth-containing quadruple therapy (esomeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, bismuth potassium citrate 220 mg) two times per day. The primary outcome is the rate of <i>H. pylori</i> eradication. Secondary outcomes are the incidence of adverse events and the gastrointestinal microbiota distribution. The 16S ribosomal RNA (16S rRNA) next-generation sequencing (NGS) is used to evaluate the effect of two different therapies on the distribution of the gastrointestinal microbiota. This study was approved by the Ethics Committee of Sichuan Cancer Center & Hospital (No. SCCHEC-02-2019-015). Any amendment to the research protocol will be submitted for ethical approval. All participants must provide informed consent. On completion, the results of the study will be published in the appropriate peer-reviewed journal. ChiCTR1900025800; preresults.