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

• Status: Not yet recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of berberine, amoxicillin and vonoprazan containing triple therapy in Helicobacter Pylori first-line eradication. It is hypothesized that berberine hydrochloride, amoxicillin and vonoprazan triple therapy is non-inferior to bismuth-containing quadruple therapy or vonoprazan -containing quadruple therapy. Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Xijing Hospital of Digestive Diseases
• Treatments: Amoxicillin; Bismuth; Clarithromycin; Rabeprazole

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.