Comparing two treatments for Helicobacter pylori infection
Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
This study is testing if a new two-drug treatment can help people who haven't been able to get rid of Helicobacter pylori infection, compared to a four-drug treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 688 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Locations | 2 sites (Xi'an, Shaanxi and 1 other locations) |
| Trial ID | NCT06168084 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of a dual therapy using Vonorazon and amoxicillin against a bismuth-containing quadruple therapy for patients who have failed previous Helicobacter pylori eradication attempts. Participants will be randomly assigned to one of the two treatment groups and will undergo a follow-up assessment to confirm the eradication of H. pylori using specific tests. The study consists of three phases: screening, treatment, and follow-up, with a total treatment duration of 14 days.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who have previously failed H. pylori eradication therapies.
Not a fit: Patients with contraindications to the study drugs or those who have previously used specific antibiotics for H. pylori eradication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative treatment for patients with resistant Helicobacter pylori infections.
How similar studies have performed: Other studies have shown varying success with different treatment regimens for H. pylori, but this specific dual therapy approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1. Age between 18\~70, both gender. 2. Patients who had failed H.pylori eradication therapies . 3. 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 who 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. 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. Mental disorder. 13. Enrolled in other clinical trials in the past 3 months. 14. Refuse to sign informed consent.
Where this trial is running
Xi'an, Shaanxi and 1 other locations
- Xijing Hosipital of Digestive Disease — Xi'an, Shaanxi, China (Recruiting)
- Xijing Hosipital of Digestive Disease — Xi'an, Shanxi, China (Recruiting)
Study contacts
- Study coordinator: Yongquan Shi,, Ph. D
- Email: shiyquan@fmmu.edu.cn
- Phone: 86-29-84771515
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.