What is vonoprazan studying for Helicobacter pylori infection?

Vonoprazan is being studied to see if adding bismuth to a 7-day high-dose amoxicillin treatment can better eliminate Helicobacter pylori infection. This trial compares this shorter combined treatment to the standard 14-day therapy to find more effective and practical options for patients. The study is sponsored by The First Affiliated Hospital with Nanjing Medical University.

Who may be eligible for this Helicobacter pylori clinical trial?

Adults aged 18 to 70 years with confirmed Helicobacter pylori infection who have not received prior eradication therapy may be eligible. Both men and women can join, but pregnant or breastfeeding women are excluded. Participants should not have allergies to study medications or serious health conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this Helicobacter pylori clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 4

Age: 18Years - 70Years

All Genders

ID07232095

7-Day Vonoprazan, High-Dose Amoxicillin, and Bismuth Treatment Compared to 14-Day Vonoprazan and Amoxicillin Therapy for Helicobacter pylori Infection

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-04-08

316

Participants Needed

Research Sites

4 weeks

Total Duration

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

Age: 18Years - 70Years

All Genders

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

Research Team

Feng Ye, PhD

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