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.
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.
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
Single group
Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days
DrugParticipants receive vonoprazan 20 mg orally twice daily plus clarithromycin 500 mg orally twice daily for 14 consecutive days.
Eradication rate of H. pylori
H. pylori eradication rate assessed by¹³C-urea breath test at 4 weeks after the completion of treatment.
incidence of adverse reactions
The incidence of adverse reactions refers to the proportion of participants who experience any adverse reactions related to the study drugs (vonoprazan and clarithromycin) during the 14-day medication period.
Compliance
Medication compliance rate (proportion of participants with good compliance, defined as compliance rate ≥ 80%).
Click on the lead sponsor to view all of their trials.
