New treatment approach for Helicobacter pylori infection

Vonoprazan-Amoxicillin Dual Sequential Therapy For Helicobacter Pylori-infected Treatment-naive Patients：A Randomized, Open-label, Parallel-controlled , Multicenter Clinical Trial

This study is testing a new two-phase treatment for Helicobacter pylori infection that combines a stomach medication with higher doses of antibiotics to see if it works better and is easier for patients to handle than the usual treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06929962 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a modified sequential therapy for Helicobacter pylori infection, which combines vonoprazan with high-dose amoxicillin in two phases. The first phase involves a standard dosage of amoxicillin, while the second phase increases the dosage to enhance efficacy and reduce side effects. The study aims to compare this new regimen with standard dual therapy over a 14-day period, focusing on eradication rates, efficacy, and patient tolerance. By gradually increasing the drug dosage, the trial seeks to improve patient adherence and minimize adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with chronic gastritis and confirmed Helicobacter pylori positivity.

Not a fit: Patients with a history of Helicobacter pylori eradication therapy or those allergic to the study medications may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective and better-tolerated option for patients suffering from Helicobacter pylori infections.

How similar studies have performed: Previous studies have shown that modified dual therapy approaches can achieve similar eradication rates with fewer side effects, indicating potential success for this novel regimen.

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.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Feng Ye, PhD

Conditions Helicobacter Pylori Infection; Helicobacter Pylori; Vonoprazan; Amoxicillin; Sequential therapy; Eradication