7-day vonoprazan with high-dose amoxicillin plus bismuth for H. pylori
7-Day Vonoprazan-High-Dose Amoxicillin-Bismuth Therapy for First-Line Eradication of Helicobacter Pylori: A Multicenter Randomized Controlled Trial
This trial tests whether adding bismuth to a 7-day vonoprazan plus high-dose amoxicillin regimen can cure H. pylori infection in adults 18–70 who have not had prior eradication therapy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 316 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07232095 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–70 with confirmed H. pylori infection who have not previously received eradication therapy and who meet local indications for treatment are ideal candidates.
Not a fit: Patients with known allergy to vonoprazan, amoxicillin, or bismuth, recent use of PPIs/P-CABs/antibiotics/bismuth/probiotics within four weeks, pregnant or lactating women, or those on prohibited concomitant medications may not receive benefit from participation.
Why it matters
Potential benefit: If successful, this regimen could achieve high eradication rates with only seven days of therapy, shortening treatment time and improving convenience for patients.
How similar studies have performed: Prior multicenter data and the 2024 ACG guideline support 14-day vonoprazan–amoxicillin therapy and showed >90% eradication with certain 10-day VA regimens, but 7-day dual therapy fell short, so adding bismuth is a plausible strategy supported by bismuth's known antibacterial synergy though not yet proven for a 7-day course.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.