Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
Yanqing Li
372 participants
Sep 9, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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
Exclusion Criteria8
- Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
- Active gastrointestinal bleeding
- History of upper gastrointestinal surgery
- History of drug hypersensitivity
- Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
- Pregnant or lactating women
- Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
- Individuals unable or unwilling to provide informed consent
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
vonoprazan 20mg bid + amoxicillin 1000mg bid
vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid
vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07179159