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Efficacy of quadruple regimen with polaprezinc for gastric Helicobacter pylori infection eradication: protocol for a single-centre, single-blind, non-inferiority, randomised clinical trial
  1. Dingkun Wu1,2,
  2. Zhen Sun3,
  3. Tingyuan Li2,
  4. Qinwen Tan2,4,
  5. Yue Sun2,
  6. Tingting Chen5,
  7. Yujing Liu6,
  8. Jun Li7,
  9. Haidong Jiang7,
  10. Zhiqiang Yuan7,
  11. Yuqian Zhao2,
  12. Wen Chen2,6
  1. 1School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
  2. 2Center for Cancer Prevention Research, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China
  3. 3Department of Gastroenterology, Jilin People's Hospital, Jilin, China
  4. 4Chongqing Medical University, Chongqing, China
  5. 5West China School of Public Health/West China Fourth Hospital, Sichuan University, Chengdu, China
  6. 6Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
  7. 7Cancer Prevention and Treatment Office, Yanting Cancer Hospital, Mianyang, China
  1. Correspondence to Dr Yuqian Zhao; gw_zhaoyuqian{at}126.com; Dr Wen Chen; chenwen{at}cicams.ac.cn

Abstract

Introduction Helicobacter pylori (H. pylori) is the most well-known risk factor for gastric cancer. At present, H. pylori shows varying levels of resistance to different treatments, leading to a lower rate of H. pylori eradication. The aim of this study is to evaluate the efficacy of polaprezinc-containing quadruple therapy (PQT) for the eradication of H. pylori infection and, thus, to provide more evidence to inform the clinical treatment of H. pylori infection in China.

Methods and analysis This is a single-centre, single-blind, non-inferiority, randomised controlled trial, enrolling 158 patients with H. pylori 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 H. pylori 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.

Ethics and dissemination 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.

Trial registration number ChiCTR1900025800; preresults.

  • gastrointestinal infections
  • gastroenterology
  • microbiology
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Footnotes

  • Contributors DW, TL, YZ and WC contributed to the study design. ZY, JL and HJ contributed to the data collection. DW, ZS, TL, QT, TC, YL, YZ, WC and YS supervised the field study. DW, ZS and TL drafted the initial manuscript. All authors have reviewed and revised the final manuscript.

  • Funding This study was supported by Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences (CIFMS) (2016-I2M-3-001).

  • Competing interests None declared.

  • Patient consent for publication Obtained.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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