Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy
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: vonoprazan, tripotassium dicitrate bismuthate, amoxicilline, rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection. Basic parameters: from 18 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 →
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Official title
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy in the First-line Anti-Helicobacter Pylori Treatment
Overview
(1) To compare the efficacy and safety of a 14-day bismuth-amoxicillin-vonoprazan triple therapy versus a 14-day bismuth-based quadruple therapy as first-line treatments for H. pylori infection, and (2) To investigate the influence of H. pylori antibiotic resistance, along with host CYP3A4, CYP2C19, and IL-1B -511 genotypes, on the eradication efficacy of H. pylori therapies.
Detailed description
This multicenter, randomized, open-label, trial will enroll 552 adult patients with H. pylori infection from 12 medical centers or regional hospitals in Taiwan. Using a computer-generated randomization sequence (1:1 allocation; block size of four), participants will be assigned to receive either the 14-day bismuth-amoxicillin-vonoprazan triple therapy or the 14-day bismuth-rabeprazole-tetracycline-metronidazole quadruple therapy. Follow-up at week 2 will assess treatment adherence and adverse events. H. pylori status will be evaluated at week 6 using the C13-urea breath test. Eradication and adverse event rates will be compared between groups using the chi-square test. The impact of H. pylori antibiotic resistance and host CYP3A4, CYP2C19, and IL-1B -511 genotypes on treatment efficacy will be analyzed using multivariate models.
Interventions
- Drug vonoprazan, tripotassium dicitrate bismuthate, amoxicilline
bismuth-amoxicillin-vonoprazan triple therapy - Drug rabeprazole, tripotassium dicitrate bismuthate, tetracycline, metronidazole
bismuth-based quadruple therapy
Primary outcome measures
- The rate of Helicobacter pylori eradication [Time frame: 6 weeks after finishing study drugs]
- Evaluation of the safety of Helicobacter pylori eradication therapy [Time frame: 14 days]
Secondary outcome measures (1)
- genotype analysis [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- Subjects with Helicobacter pylori infection
Exclusion criteria
- Subjects with known hypersensitivity to the study drug.
- Subjects with a history of gastric surgery.
- Subjects with severe liver cirrhosis or uremia.
- Subjects with a history of malignancy within the past five years.
- Pregnant or breastfeeding women.
- Subjects currently receiving treatment with atazanavir sulfate or rilpivirine hydrochloride.
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
- Kaohsiung Medical University Hospital — Kaohsiung City
Identifiers
NCT: NCT07358130 · KMUHIRB-F(I)-20250254