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

Launched by YONGQUAN SHI · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the best way to treat an infection caused by a bacteria called Helicobacter pylori, which can lead to stomach problems like gastritis, ulcers, and even increase the risk of stomach cancer. The study is comparing how well a medicine called vonoprazan works when combined with different antibiotics to clear this infection. People who have just been diagnosed with Helicobacter pylori and have not yet received treatment are being invited to join. Participants will be divided into groups and given different combinations of medicines. After about six weeks, tests will be done to see if the infection has been successfully removed.

To join this study, you need to be between 18 and 70 years old and have a confirmed Helicobacter pylori infection based on specific tests. Women who can have children will need to use birth control during the study and for a short time afterward. If you have had previous treatment for this infection, serious health problems, recent use of certain stomach or antibiotic medicines, or if you are pregnant or breastfeeding, you would not be eligible. During the study, you can expect to take the prescribed medicines and come back for follow-up tests to check if the treatment worked. This trial is still recruiting participants and aims to find a simpler, effective way to get rid of the infection using fewer medicines.

Gender

ALL

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.