Simplified Dual Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line H. Pylori Eradication
Efficacy and Safety of Simplified Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line Helicobacter Pylori Eradication
Peking University First Hospital
70 participants
Apr 25, 2026
INTERVENTIONAL
Conditions
Summary
To investigate the efficacy, safety, and compliance of a simplified strategy using vonoprazan plus clarithromycin for first-line treatment in patients with Helicobacter pylori infection, among those infected with strains without clarithromycin resistance gene mutations based on fecal clarithromycin resistance gene detection.
Eligibility
Inclusion Criteria3
- Aged 18-70 years;
- Positive results for both ¹³C-urea breath test (¹³C-UBT) and fecal polymerase chain reaction (PCR), confirming Helicobacter pylori infection, with a clinical indication for H. pylori eradication as judged by the physician;
- Treatment-naïve individuals with no prior history of H. pylori eradication therapy.
Exclusion Criteria5
- Pregnant or lactating women
- Patients with a history of allergy to any drugs used in the eradication regimen
- Patients with severe systemic diseases or malignant tumors
- History of gastric resection surgery
- Recent use of antibiotics or bismuth salts (within 4 weeks), H₂-receptor antagonists, proton pump inhibitors (PPIs), or Potassium-competitive acid blockers(P-CABs) (within 2 weeks).
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Interventions
Participants receive vonoprazan 20 mg orally twice daily plus clarithromycin 500 mg orally twice daily for 14 consecutive days.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07439445