Clinical trial · Interventional
Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dyspepsia | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastritis | — | UNRESOLVED | — |
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
| Peptic Ulcer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amoxicillin | Drug | — | UNRESOLVED |
| Bismuth | Drug | — | UNRESOLVED |
| Esomeprazole | Drug | — | UNRESOLVED |
| Furazolidone | Drug | — | UNRESOLVED |
| Tetracycline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-dose esomeprazole and amoxicillin dual therapy
- description
- Esomeprazole 40 mg and amoxicillin 1000 mg by mouth,three time daily for 14 days
- interventionNames
- Drug: Esomeprazole
- Drug: Amoxicillin
- type
- ACTIVE_COMPARATOR
- label
- Bismuth-containing quadruple therapy
- description
- Tetracycline 500mg three time daily for 14 days,furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
- interventionNames
- Drug: Bismuth
- Drug: Esomeprazole
- Drug: Tetracycline
- Drug: Furazolidone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDBi H, Chen X, Chen Y, Zhao X, Wang S, Wang J, Lyu T, Han S, Lin T, Li M, Yuan D, Liu J, Shi Y. Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial. Chin Med J (Engl). 2022 Jul 20;135(14):1707-1715. doi: 10.1097/CM9.0000000000002289. PMID 36193978