Effect of Bismuth Add-on to Dual Therapy for Helicobacter Pylori Eradication
Effect of Bismuth Add-on to Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Eradication - A Multicenter Randomized Controlled Trial
National Taiwan University Hospital
990 participants
Apr 8, 2026
INTERVENTIONAL
Conditions
Summary
This study aims to compare the efficacy and safety of a bismuth-supplemented 14-day vonoprazan-based dual therapy ( triple therapy) versus a 14-day vonoprazan-based dual therapy without bismuth for first-line H. pylori eradication. Furthermore, the investigators will investigate the impact of these eradication regimens on the gut microbiota, the development of antibiotic resistance, and changes in metabolic syndrome indicators pre- and post-treatment.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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.
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Interventions
bismuth, vonoprazan and amoxicillin for 14 days
vonoprazan and amoxicillin for 14 days
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07576959