Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication

Background: Although bismuth is not an antibiotic, it enhances antibiotic efficacy through multiple synergistic mechanisms. Currently, it remains unknown whether adding bismuth to a 14-day bismuth-vonoprazan-amoxicillin triple therapy is superior or non-inferior to the vonoprazan-amoxicillin dual therapy alone.

Objectives: This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based triple therapy versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication.

Hypothesis: The investigators hypothesize that the efficacy of a 14-day bismuth-vonoprazan triple therapy is superior or non-inferior to that of a 14-day vonoprazan-based dual therapy without bismuth.

Methods:

Study Design: An open-label, randomized controlled trial (RCT). Participants: The investigators intend to recruit 990 treatment-naïve patients with confirmed H. pylori infection.

Intervention and Randomization: Eligible participants will be randomized into one of two groups:

• Group A: 14-day bismuth-vonoprazan triple therapy.
• Group B: 14-day vonoprazan-based dual therapy (without bismuth).

Inclusion criteria

• Individuals infected with Helicobacter pylori who have not previously undergone eradication therapy.
• Individuals willing to receive first-line eradication therapy.
• Study participants must be 20 years of age or older.

Exclusion criteria

• Individuals with a history of gastrectomy (stomach removal surgery).
• Individuals unsuitable to receive the study drug (e.g., history of allergy or severe adverse effects to the study drug).
• Pregnant or breastfeeding women.
• Individuals with severe acute or chronic diseases, such as renal failure, liver cirrhosis, or incurable malignant tumors.
• Patients with chronic hepatitis (AST [Aspartate Aminotransferase] or ALT [Alanine Aminotransferase] > 100 U/L).
• Individuals unwilling to comply with the treatment plan or sign the informed consent form.