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

The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.

Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.

Inclusion criteria

• Aged 18 - 70 years, regardless of gender;
• 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;
• 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

• Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment;
• Patients with contraindications to the study drug or who are allergic to the study drug;
• Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases;
• 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);
• Pregnant and lactating women;
• Patients who have undergone upper gastrointestinal surgery;
• Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia;
• Patients with symptoms of dysphagia;
• Patients with evidence of bleeding or iron - deficiency anemia;
• Patients with a history of malignant tumors;
• Patients with a history of drug or alcohol abuse within the past 1 year;
• Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d);
• Patients with mental disorders;
• Patients who have participated in other clinical trials within the past 3 months;
• Patients who refuse to sign the informed consent form.