Study on the Efficacy and Safety of Berberine, Minocycline, Esomeprazole, and Colloidal Bismuth Quadruple Therapy in the Initial Treatment of Helicobacter Pylori.

Launched by XIJING HOSPITAL OF DIGESTIVE DISEASES · Sep 17, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for Helicobacter pylori infection, which can cause stomach problems like chronic gastritis. The study is testing a combination of four medications: berberine, minocycline, esomeprazole, and colloidal bismuth. Researchers want to see if this new treatment works as well as a standard treatment that includes amoxicillin and clarithromycin. If you participate, you will be randomly assigned to receive one of these treatments. After six weeks, tests will be done to check if the bacteria have been successfully eliminated from your system.

To be eligible for this study, you should be between 18 and 70 years old and have symptoms related to your upper digestive system, along with a confirmed Helicobacter pylori infection. You must not have received treatment for this infection before and should be willing to take the medications. There are some exclusions, such as having certain severe health conditions or being pregnant. If you join the study, you'll receive care and monitoring throughout the trial, and your participation could help improve treatment options for others with similar conditions.

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.