Effect of Bismuth Add-on to Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Eradication - A Multicenter Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 990
- Locations
- 1
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.