Menu
Recruiting NCT07576959

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

Phase III Interventional HELICOBACTER PYLORI INFECTIONS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bismuth Add-on to Vonoprazan Dual Therapy, Vonoprazan dual therapy.
Who it may be relevant to
Registry conditions: HELICOBACTER PYLORI INFECTIONS. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Bismuth Add-on to Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Eradication - A Multicenter Randomized Controlled Trial

Overview

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.

Detailed 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).

Interventions

  • Drug Bismuth Add-on to Vonoprazan Dual Therapy
    bismuth, vonoprazan and amoxicillin for 14 days
  • Drug Vonoprazan dual therapy
    vonoprazan and amoxicillin for 14 days

Primary outcome measures

  • Eradication rate determined by Intention-to-Treat (ITT) analysis [Time frame: 6-8 weeks]
Secondary outcome measures (1)
  • Per-protocol (PP) eradication rate; adverse event profiles [Time frame: 6-8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT07576959 · 202602016MINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗