VA Dual Sequential Therapy

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Apr 8, 2025

Keywords

ClinConnect Summary

The VA Dual Sequential Therapy trial is studying a new way to treat Helicobacter pylori (H. pylori) infections, which can cause stomach issues like chronic gastritis. The researchers want to see if a modified treatment using a combination of vonoprazan (a medication that reduces stomach acid) and high-dose amoxicillin (an antibiotic) is more effective than the standard treatment. The trial involves two experimental groups that will take the new treatment for either 10 or 14 days, and they will be compared to a control group receiving standard therapy. The goal is to find out if this new approach can better get rid of the infection while reducing side effects.

To join the study, participants must be between 18 and 70 years old and have a confirmed H. pylori infection along with chronic gastritis. They should not have been treated for H. pylori before and must be able to give consent to participate. Throughout the trial, participants will take medications as directed and will be monitored for their response and any side effects. This study is currently recruiting and aims to help find a better treatment option for those suffering from H. pylori-related stomach issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18-70 years, gender unrestricted.
• • 2. Chronic gastritis patients with Helicobacter pylori positivity: (1) Helicobacter pylori positive is defined as a positive result on a carbon-13 or carbon-14 breath test within one month prior to enrollment; (2) Chronic gastritis is defined as a diagnosis based on gastroscopy within six months prior to enrollment.
• • 3. No previous Helicobacter pylori eradication therapy.
• • 4. Agree to participate in the trial and sign the informed consent form
• Exclusion Criteria:
• • 1. Allergy to any of the drugs used in this clinical trial.
• • 2. Previously received H. pylori eradication treatment.
• • 3. Receiving Potassium-competitive acid blocker (P-CAB), proton pump inhibitor (PPI), H2 receptor antagonist, antibiotics, bismuth, probiotic preparations 4 weeks before initiating study treatment.
• • 4. Use of non-steroidal anti-inflammatory drugs (NSAIDs), adrenal corticosteroids, or anticoagulants during the study period.
• • 5. Pregnant or lactating women, or patients planning to conceive during the study period.
• • 6. Patients with hepatic or renal dysfunction, or those with severe concomitant diseases that may affect the evaluation of this study, such as heart disease, lung disease, liver disease, kidney disease, metabolic disorders, mental illnesses, malignant tumors, etc..
• • 7. Gastroscopy findings indicating conditions other than gastritis, such as reflux esophagitis, which require continued use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H2 receptor antagonists, or bismuth after Helicobacter pylori eradication.
• • 8. Patients with a history of gastric surgery.
• • 9. Patients who are unable to accurately express their symptoms, such as those with psychiatric disorders or severe neurosis, and are unable to cooperate with the trial.
• • 10. Patients who have participated in other drug studies within 3 months before using the investigational drug.
• • 11. Other conditions deemed by the investigator as unsuitable for participation in this trial.