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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorYanqing Li

About this trial

This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.

Eligibility criteria

Qualifiers

Aged 18-70 years, male or female

Patients with H. pylori infection (positive 13C-urea breath test, together with at least one positive result from the following three tests: (a) stool H. pylori antigen test; (b) rapid urease test; (c) histopathological examination of gastric mucosal biopsy tissue)

No prior Helicobacter pylori eradication therapy

Disqualifiers

Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours

Active gastrointestinal bleeding

History of upper gastrointestinal surgery

History of drug hypersensitivity

Trial design

Treatments tested in this trial

  • 14-day vonoprazan-amoxicillin dual therapy
  • 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy
  • 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy

Treatment groups

372 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Yanqing Li

Lead sponsor

Shandong University

Sponsor institution

Longkou People's Hospital

Collaborator

Qingdao Jimo People's Hospital

Collaborator

Shandong University of Traditional Chinese Medicine

Collaborator

Dezhou Hospital Qilu Hospital of Shandong University

Collaborator

Zibo Maternal and Child Health Hospital

Collaborator

Guanxian County People's Hospital

Collaborator

Yantai Zhifu Hospital

Collaborator

Dongying No. 2 People's Hospital

Collaborator

Qilu Hospital of Shandong University

Collaborator