Clinical trial · Interventional
Efficacy Comparison of Vonoprazan Combined With Different Antibiotics in Dual Therapy for Helicobacter Pylori Eradication: A Prospective, Randomized Controlled Clinical Trial
NCT07068607CI-TRIAL-00093622recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amoxicillin | Drug | — | UNRESOLVED |
| Bismuth | Drug | — | UNRESOLVED |
| Clarithromycin 500 mg | Drug | — | UNRESOLVED |
| Minocycline | Drug | — | UNRESOLVED |
| Tetracycline 500mg tid | Drug | — | UNRESOLVED |
| Vonoprazan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Vonoprazan - amoxicillin dual therapy
- description
- Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days
- interventionNames
- Drug: Vonoprazan
- Drug: Amoxicillin
- type
- EXPERIMENTAL
- label
- Vonoprazan-tetracycline dual therapy
- description
- Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days
- interventionNames
- Drug: Vonoprazan
- Drug: Tetracycline 500mg tid
- type
- EXPERIMENTAL
- label
- Vonoprazan-minocycline dual therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 - 70 years, regardless of gender; 2. Patients with definite Hp infection (positive result in any one of the 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) who have never received Helicobacter pylori eradication treatment; 3. For women of child - bearing age, it is required to use medically acceptable contraceptive methods during the trial period and within 30 days after the end of the trial. Exclusion Criteria: 1. Patients who have been definitely diagnosed with Hp infection and have received antibiotic eradication treatment; 2. Patients with contraindications to the study drug or who are allergic to the study drug; 3. Patients with severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases; 4. Patients who have been continuously using anti - ulcer drugs (including taking PPI within 2 weeks before the Hp infection test), antibiotics or bismuth complexes (more than 3 times a week within 1 month before screening); 5. Pregnant and lactating women; 6. Patients who have undergone upper gastrointestinal surgery; 7. Patients with moderate or severe atypical hyperplasia or high - grade intraepithelial neoplasia; 8. Patients with symptoms of dysphagia; 9. Patients with evidence of bleeding or iron - deficiency anemia; 10. Patients with a history of malignant tumors; 11. Patients with a history of drug or alcohol abuse within the past 1 year; 12. Patients who are using systemic glucocorticoids, non - steroidal anti - inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for using aspirin ≤ 100 mg/d); 13. Patients with mental disorders; 14. Patients who have participated in other clinical trials within the past 3 months; 15. Patients who refuse to sign the informed consent form.
References
Publications (1)
- DERIVEDLi J, Li DH, Guo QQ, Zhang J, Zhu XJ, Liu YH, Zhang YP, Chen M, Shi YQ. Efficacy and Safety of Vonoprazan-Based Dual Therapies With Different Antibiotics Versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Eradication: A Prospective, Four-Arm, Randomized Controlled Trial. Helicobacter. 2026 May-Jun;31(3):e70132. doi: 10.1111/hel.70132. PMID 42141850