Vonoprazan plus different antibiotics to clear H. pylori infection

Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial

This trial will test whether vonoprazan paired with different antibiotic combinations can clear H. pylori in adults who have never had eradication treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07068607 on ClinicalTrials.gov

What this trial studies

Adults with confirmed H. pylori infection are randomly assigned to one of four treatment groups (vonoprazan+amoxicillin dual therapy, vonoprazan+tetracycline dual therapy, vonoprazan+minocycline dual therapy, or bismuth quadruple therapy) and receive 14 days of assigned treatment. The protocol includes a screening phase, a randomized treatment phase, and a follow-up visit about 28 days after treatment completion. Eradication is confirmed at follow-up by urea breath test, rapid urease test, or stool antigen test. The trial is conducted at a single center with visits on Day 0, at end of treatment (Day 14–16), and at the post-treatment follow-up.

Who should consider this trial

Good fit: Adults aged 18–70 with a confirmed H. pylori infection who have never received eradication therapy (and women of childbearing potential willing to use contraception) are ideal candidates.

Not a fit: Patients who have previously received H. pylori eradication therapy, who have contraindications or allergies to the study drugs, or who have severe organ failure are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could identify simpler or more effective antibiotic combinations with vonoprazan to improve H. pylori cure rates.

How similar studies have performed: Previous studies have shown vonoprazan plus amoxicillin can be effective, but direct head-to-head comparisons among these specific antibiotic combinations are limited.

Eligibility criteria

Inclusion Criteria:

1. Aged 18 - 70 years, regardless of gender;
2. Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment;
3. For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial.

Exclusion Criteria:

1. Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
2. Patients with contraindications to the study drug or who are allergic to the study drug;
3. Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
4. Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before screening);
5. Pregnant and lactating women;
6. Patients who have undergone upper gastrointestinal surgery;
7. Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia;
8. Patients with symptoms of dysphagia;
9. Patients with evidence of bleeding or iron - deficiency anemia;
10. Patients with a history of malignant tumors;
11. Patients with a history of drug or alcohol abuse within the past 1 year;
12. Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d);
13. Patients with mental disorders;
14. Patients who have participated in other clinical trials within the past 3 months;
15. Patients who refuse to sign the informed consent form.

Where this trial is running

Xi'an, Shaanxi

• Xijing Hosipital of Digestive Disease — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Yongquan Shi, Ph. D

Conditions Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer