Clinical trial · Interventional
Helicobacter Rescue Therapy With Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy
Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone 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 berberine- amoxicillin containing quadruple therapy(berberine, amoxicillin, esomeprazole and bismuth) versus tetracycline-furazolidone quadruple therapy (tetracycline, furazolidone, esomeprazole and bismuth) in H. pylori rescue therapy. It is hypothesized that berberine-amoxicillin containing quadruple therapy is non-inferior to tetracycline-furazolidone 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 |
|---|---|---|---|
| Chronic Gastritis | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Ulcer | — | UNRESOLVED | — |
| Gastritis | — | UNRESOLVED | — |
| Helicobacter Pylori Infection | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amoxicillin | Drug | — | UNRESOLVED |
| Berberine | Drug | — | UNRESOLVED |
| Bismuth | Drug | — | UNRESOLVED |
| Esomeprazole | Drug | — | UNRESOLVED |
| Furazolidone | Drug | — | UNRESOLVED |
| Tetracycline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- berberine plus amoxicillin quadruple therapy
- description
- Berberine 500mg three time daily for 14days, amoxicillin 1000 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.
- interventionNames
- Drug: Berberine
- Drug: Amoxicillin
- Drug: Esomeprazole
- Drug: Bismuth
- type
- ACTIVE_COMPARATOR
- label
- tetracycline plus furazolidone quadruple therapy
- description
- Tetracycline 500mg three time daily for 14days,furazolidone 100 mg, esomeprazole 20 mg, and Bismuth 200mg by mouth, twice daily for 14 days.
- interventionNames
- Drug: Tetracycline
- Drug: Furazolidone
- Drug: Esomeprazole
- Drug: Bismuth
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 2 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 Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia. 8. Evidence of bleeding or iron efficiency anemia. 9. A history of malignancy. 10. Drug or alcohol abuse history in the past 1 year. 11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). 12. Enrolled in other clinical trials in the past 3 months. 13. Patients who has psychological problem or poor compliance. 14. Refuse to sign informed consent.
References
Publications (1)
- DERIVEDZhang J, Han C, Lu WQ, Wang N, Wu SR, Wang YX, Ma JP, Wang JH, Hao C, Yuan DH, Liu N, Shi YQ. A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment. J Dig Dis. 2020 May;21(5):256-263. doi: 10.1111/1751-2980.12870. Epub 2020 Jun 9. PMID 32348007