Actively Recruiting
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy in the First-line Anti-Helicobacter Pylori Treatment
Led by Kaohsiung Medical University · Updated on 2026-01-22
552
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
Sponsors
K
Kaohsiung Medical University
Lead Sponsor
K
Kaohsiung Veterans General Hospital.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two different 14-day treatment regimens for adults infected with Helicobacter pylori. The study compares a triple therapy consisting of bismuth, amoxicillin, and vonoprazan to a quadruple therapy including bismuth, rabeprazole, tetracycline, and metronidazole. Additionally, the study aims to understand how antibiotic resistance and specific genetic factors related to the host affect treatment success. Participants will be randomly assigned to one of two groups: one receiving the bismuth-amoxicillin-vonoprazan triple therapy and the other receiving the bismuth-based quadruple therapy. Both treatments are taken over 14 days. The triple therapy involves vonoprazan 20 mg twice daily, tripotassium dicitrate bismuthate 300 mg four times daily, and amoxicillin 750 mg four times daily. The quadruple therapy includes rabeprazole 20 mg twice daily, tripotassium dicitrate bismuthate 300 mg four times daily, tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily. During the study, participants will be followed up at 2 weeks to check adherence to treatment and any side effects. At 6 weeks, the Helicobacter pylori infection status will be assessed using a C13-urea breath test. Researchers will compare eradication rates and adverse events between the two groups and analyze how antibiotic resistance and genetic factors influence outcomes. The study involves 552 adults across multiple medical centers and lasts through the treatment and follow-up periods.
CONDITIONS
Brief Title
Efficacies of Bismuth-amoxicillin-vonoprazan Triple Therapy and Bismuth Quadruple Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with Helicobacter pylori infection
You will not qualify if you...
- Known allergy to any study drug
- History of gastric surgery
- Severe liver cirrhosis or uremia
- History of cancer within the past 5 years
- Pregnant or breastfeeding women
- Currently receiving atazanavir sulfate or rilpivirine hydrochloride
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 14 days
Participants receive either a 14-day bismuth-amoxicillin-vonoprazan triple therapy or a 14-day bismuth-based quadruple therapy to eradicate Helicobacter pylori.
1 baseline visit and 1 follow-up visit at week 2
Duration - Up to 6 weeks after finishing treatment
Participants are assessed for Helicobacter pylori eradication and safety of therapy.
1 visit at week 6
Trial Site Locations
Total: 1 location
1
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
Research Team
D
Deng-Chyang Wu, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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