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
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