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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2032
  • participants needed
    990
  • sponsor
    National Taiwan University Hospital
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Updated on 8 May 2026
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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.

Description

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).

Details
Condition HELICOBACTER PYLORI INFECTIONS
Age 20years or above
Clinical Study IdentifierNCT07576959
SponsorNational Taiwan University Hospital
Last Modified on8 May 2026

Eligibility

 Yes No Not Sure

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
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