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

RecruitingPhase 3Ages 20 Years - anyAllNational Taiwan University Hospital
NCT07576959 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Individuals infected with Helicobacter pylori who have not previously undergone eradication therapy. 2. Individuals willing to receive first-line eradication therapy. 3. Study participants must be 20 years of age or older. Exclusion Criteria: 1. Individuals with a history of gastrectomy (stomach removal surgery). 2. Individuals unsuitable to receive the study drug (e.g., history of allergy or severe adverse effects to the study drug). 3. Pregnant or breastfeeding women. 4. Individuals with severe acute or chronic diseases, such as renal failure, liver cirrhosis, or incurable malignant tumors. 5. Patients with chronic hepatitis (AST \[Aspartate Aminotransferase\] or ALT \[Alanine Aminotransferase\] \> 100 U/L). 6. Individuals unwilling to comply with the treatment plan or sign the informed consent form.
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What it tests

  • Bismuth Add-on to Vonoprazan Dual Therapy
  • Vonoprazan dual therapy
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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