Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

• Status: Enrolling by invitation
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

Summary

This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. 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?: No

Details

• Lead Sponsor: Xijing Hospital of Digestive Diseases
• Treatments: Amoxicillin; Bismuth; Esomeprazole; Furazolidone; Tetracycline

Criteria

Inclusion Criteria:

1. Patients who had failed H.pylori eradication therapies before.

2. Age between 18~70, both gender.

3. Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 3 months.

4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

1. Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.

2. Contraindications to study drugs.

3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.

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. Pregnant or lactating women.

6. Underwent upper gastrointestinal Surgery.

7. Patients with moderate or severe atypical hyperplasia or high-grade intraepithelial neoplasia.

8. have symptom of dysphagia.

9. Evidence of bleeding or iron efficiency anemia.

10. A history of malignancy.

11. Drug or alcohol abuse history in the past 1 year.

12. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).

13. a person with a mental disorder.

14. Enrolled in other clinical trials in the past 3 months.

15. Refuse to sign informed consent.