Comparison of Safety and Efficacy of Vonoprazan based High dose amoxicillin dual therapy with Esomeprazole based Standard triple therapy for H pylori eradication in Eastern India: A single centre double blind Randomized trial

Helicobacter pylori is a gram-negative microaerophilic bacterium that colonizes the human stomach and remains highly prevalent worldwide. Although the global prevalence has declined in recent decades, H. pylori infection continues to be a major public health problem and is associated with peptic ulcer disease, chronic gastritis, and progression to gastric cancer. Successful eradication of the infection can reduce gastric mucosal damage and lower the risk of gastric malignancy.

Currently recommended eradication regimens include clarithromycin-based triple therapy and bismuth-containing quadruple therapy. However, these regimens are increasingly limited by rising antibiotic resistance, particularly to clarithromycin, metronidazole, and levofloxacin, as well as issues related to multiple drug combinations, increased adverse effects, and poor patient compliance.

High-dose amoxicillin dual therapy combined with potent acid suppression has emerged as a promising alternative approach. Recently, Vonoprazan, a potassium-competitive acid blocker, has shown stronger and more sustained acid inhibition compared with traditional proton pump inhibitors such as Esomeprazole. This may improve the efficacy of amoxicillin-based dual therapy.

However, evidence comparing vonoprazan-based high-dose dual therapy with standard proton pump inhibitor-based triple therapy in the Indian population is limited. Therefore, this randomized controlled trial aims to evaluate the safety and efficacy of these treatment regimens for H. pylori eradication in Eastern India.