7-day vonoprazan with high-dose amoxicillin plus bismuth for H. pylori

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 4 trial compares a 7-day vonoprazan–amoxicillin–bismuth regimen (VAB-7) with the guideline-recommended 14-day vonoprazan–amoxicillin dual therapy (VA-14) in adults with confirmed H. pylori infection. Eligible participants are aged 18–70, have a positive 13C/14C urea breath test or endoscopy confirmation, and have not received prior eradication therapy. The protocol excludes recent users of acid suppressants, antibiotics, bismuth, or probiotics, and excludes those with known allergies or pregnancy. The primary outcome is H. pylori eradication by urea breath test, with safety and tolerability monitored during and after treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 to 70 years, regardless of sex.
2. Helicobacter pylori infection confirmed by ¹³C or ¹⁴C urea breath test within 1 month before enrollment.
3. Chronic gastritis with H. pylori infection confirmed by endoscopy within 3 months, meeting the indications for eradication therapy in the Sixth National Consensus Report on the Management of Helicobacter pylori Infection (China), and willing to receive eradication treatment.
4. No prior H. pylori eradication therapy.
5. Written informed consent before participation.

Exclusion Criteria:

1. Known allergy or hypersensitivity to any study medication (vonoprazan, amoxicillin, or bismuth).
2. Use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H₂ receptor antagonists, antibiotics, bismuth preparations, or probiotics within 4 weeks before enrollment.
3. Pregnant or lactating women.
4. Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or anticoagulants during the study period.
5. Presence of serious comorbid conditions that may interfere with study evaluation, including significant cardiac, pulmonary, hepatic, renal, metabolic, or psychiatric disorders, or malignancy.
6. History of gastric or esophageal surgery.
7. Any condition or factor that may affect compliance or make it difficult for the subject to complete follow-up as required.

Where it's running

• The First Affiliated Hospital with Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Feng Ye, PhD
• Email: fengye@njmu.edu.cn
• Phone: 86+13815897873

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.