Study on The Efficacy and Safety of Vonoprazan-containing Berberine Triple Therapy in Helicobacter Pylori First-Line Eradication

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Jul 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for a common stomach infection called Helicobacter pylori (H. pylori), which can cause chronic gastritis and other gastrointestinal issues. The treatment being tested combines three medications: berberine hydrochloride, vonoprazan, and amoxicillin. Researchers want to see if this combination is as effective and safe as a different treatment that includes bismuth. If you have been diagnosed with H. pylori and have not received treatment for it yet, you might be eligible to participate in this study.

To qualify, you should be between 18 and 70 years old and have upper stomach symptoms linked to H. pylori. Participants will be randomly assigned to receive either the new treatment or the standard one, and after six weeks, tests will be conducted to check if the infection has been successfully cleared. It’s important to know that certain health conditions, past treatments, and medications could disqualify you from joining. If you are interested, you will need to agree to participate and follow the study's guidelines, including using birth control if you are a woman of childbearing age.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18\~70,both gender.
• • 2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
• • 3. Patients are willing to receive eradication treatment.
• • 4. Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
• Exclusion Criteria:
• • 1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
• • 2. Patients with contraindications or allergies to the study drug.
• • 3. Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
• • 4. Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
• • 5. Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
• • 6. Pregnant or lactating women.
• • 7. Underwent upper gastrointestinal Surgery.
• • 8. Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.
• • 9. Patients have symptom of dysphagia.
• • 10. Evidence of bleeding or iron efficiency anemia.
• • 11. A history of malignancy.
• • 12. Drug or alcohol abuse history in the past 1 year.
• • 13. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
• • 14. Patients who has psychological problem or poor compliance.
• • 15. Enrolled in other clinical trials in the past 3 months.
• • 16. Refuse to sign informed consent.