Actively Recruiting
7-Day Vonoprazan-High-Dose Amoxicillin-Bismuth Therapy for First-Line Eradication of Helicobacter Pylori: A Multicenter Randomized Controlled Trial
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-04-08
316
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a 7-day treatment combining vonoprazan, high-dose amoxicillin, and bismuth (VAB-7) to treat Helicobacter pylori infection. This infection can cause chronic stomach inflammation and increase risks for ulcers, lymphoma, and gastric cancer. The study compares this shorter regimen with the standard 14-day vonoprazan and high-dose amoxicillin dual therapy (VA-14) due to concerns about antibiotic resistance and the need for more effective treatments. Participants are randomly assigned to one of two groups. The experimental group receives vonoprazan 20 mg twice daily, amoxicillin 1 g three times daily, and bismuth 220 mg twice daily for 7 days. The control group receives vonoprazan 20 mg twice daily and amoxicillin 1 g three times daily for 14 days. The study explores whether adding bismuth can improve eradication rates in a shorter treatment course. During the study, researchers monitor participants for Helicobacter pylori eradication using a urea breath test conducted 4 to 6 weeks after treatment. They also assess patient adherence, adverse events during treatment days, and cost-effectiveness. Follow-up assessments occur shortly after treatment completion to evaluate safety and compliance. The total study duration for each participant varies based on their assigned treatment group.
CONDITIONS
Brief Title
7-Day Vonoprazan, High-Dose Amoxicillin, and Bismuth Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, regardless of sex
- Confirmed Helicobacter pylori infection by urea breath test within 1 month before enrollment
- Chronic gastritis with H. pylori infection confirmed by endoscopy within 3 months and meeting indications for eradication therapy
- No prior Helicobacter pylori eradication therapy
- Provided written informed consent before participation
You will not qualify if you...
- Allergy or hypersensitivity to vonoprazan, amoxicillin, or bismuth
- Use of P-CABs, PPIs, H2 receptor antagonists, antibiotics, bismuth, or probiotics within 4 weeks before enrollment
- Pregnant or lactating women
- Use of NSAIDs, corticosteroids, or anticoagulants during the study
- Serious cardiac, pulmonary, hepatic, renal, metabolic, psychiatric disorders, or malignancy
- History of gastric or esophageal surgery
- Any condition that may affect compliance or make follow-up difficult
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.
1 visit (in-person)
Duration - 7 or 14 days depending on assigned treatment group
Participants receive either a 7-day vonoprazan, high-dose amoxicillin, and bismuth therapy or a 14-day vonoprazan and high-dose amoxicillin therapy to eradicate Helicobacter pylori infection.
Visits on Day 3 and Day 7 for the 7-day treatment group; Visits on Day 7 and Day 14 for the 14-day treatment group
Duration - 4 to 6 weeks after treatment completion
Participants undergo assessment of Helicobacter pylori eradication and safety monitoring after treatment completion.
1 visit for ¹³C-urea breath test and safety assessment
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
F
Feng Ye, 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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