Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy for Hp Eradication
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, amoxicillin, tripotassium dicitrate bismuthate, vonoprazan, amoxicillin, rabeprazole, amoxicillin, clarithromycin.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Eradication. 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, Vonoprazan-amoxicillin Dual Therapy and Proton Pump Inhibitor-based Standard Triple Therapy in the First-line Anti-H. Pylori Treatment
Overview
1. Compare the efficacies and safety of 14-day bismuth-amoxicillin-vonoprazan tiple therapy, 14-day vonoprazan dual therapy and 14-day rabeprazole triple therapy in the first-line treatment of H. pylori infection. 2. To investigate the impacts of antibiotic resistance of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of anti-H. pylori treatments.
Detailed description
For this multi-center, randomized, open-label, superiority trial, we will recruit 780 adult patients with H. pylori infection from ten medical centers or regional hospitals in Taiwan. Using a computer generated randomized sequence, we randomly allocate patients (1:1:1; block size of six) to either 14-day bismuth-amoxicillin-vonoprazan triple therapy, 14-day vonoprazan dual therapy, or 14-day rabeprazole-triple therapy. Patients are asked to return at the second week to assess drug adherence and adverse events. Post-treatment H. pylori status is assessed by 13C-urea breath test at week 6. Participants with failure of H. pylori eradication will randomly receive either 14-day vonoprazan-based or 14-day esomeprazole-based bismuth quadruple therapy. Finally, the rates of eradication and adverse events will be compared between groups by chi-square test. Additionally, the effects of antibiotic resistances of H. pylori as well as CYP3A4, CYP2C19 and IL-1B -511 genotypes of host on the eradication efficacies of above first-line and second-line anti-H. pylori treatments are assessed by multivariate analysis.
Interventions
- Drug vonoprazan, amoxicillin, tripotassium dicitrate bismuthate
bismuth-amoxicillin-vonoprazan triple therapy - Drug vonoprazan, amoxicillin
vonoprazan-amoxicillin dual therapy - Drug rabeprazole, amoxicillin, clarithromycin
proton pump inhibitor-based standard triple therapy
Primary outcome measures
- the eradication rate of Helicobacter pylori [Time frame: 8 week after finishing study drugs]
Secondary outcome measures (1)
- genotype analysis [Time frame: 1 day]
Eligibility criteria
Inclusion criteria
(1) At least 18 years old. (2) Subjects infected with Helicobacter pylori.
Exclusion criteria
- Those who have ever received Helicobacter pylori sterilization treatment.
- Those who are allergic to the drugs used in this research.
- Those who have had stomach surgery.
- Those with severe liver cirrhosis or uremia or malignant tumors.
- Women who are pregnant or breastfeeding.
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: NCT06349486 · KMUHIRB-F(II)-20230179