HELICOBACTER PYLORI INFECTIONS
Conditions
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. 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
DRUGBismuth Add-on to Vonoprazan Dual Therapy
bismuth, vonoprazan and amoxicillin for 14 days
vonoprazan and amoxicillin for 14 days
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individuals infected with Helicobacter pylori who have not previously undergone eradication therapy. 2. Individuals willing to receive first-line eradication therapy. 3. Study participants must be 20 years of age or older.
Exclusion criteria
1. Individuals with a history of gastrectomy (stomach removal surgery). 2. Individuals unsuitable to receive the study drug (e.g., history of allergy or severe adverse effects to the study drug). 3. Pregnant or breastfeeding women. 4. Individuals with severe acute or chronic diseases, such as renal failure, liver cirrhosis, or incurable malignant tumors. 5. Patients with chronic hepatitis (AST \[Aspartate Aminotransferase\] or ALT \[Alanine Aminotransferase\] \> 100 U/L). 6. Individuals unwilling to comply with the treatment plan or sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate determined by Intention-to-Treat (ITT) analysis | 6-8 weeks | Eradication rate will be determined by urea breath test at least 6 weeks later after completion of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per-protocol (PP) eradication rate; adverse event profiles | 6-8 weeks | Eradication rate will be determined by urea breath test at least 6 weeks later after completion of treatment. A standard interview and questionaire will be used toassess the adverse effects. |
Countries
Taiwan
Contacts
CONTACTMei-Jyh Chen, MD, PhD
Outcome results
None listed