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

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

Inclusion Criteria:

1. Aged 18-70 years, male or female
2. 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)
3. No prior Helicobacter pylori eradication therapy

Exclusion Criteria:

1. Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours
2. Active gastrointestinal bleeding
3. History of upper gastrointestinal surgery
4. History of drug hypersensitivity
5. Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks
6. Pregnant or lactating women
7. Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use
8. Individuals unable or unwilling to provide informed consent