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Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma. Guideline recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on invasive endoscopic biopsy for tissue acquisition, and 2) dependency on bacterial culture, which is complex and time-consuming. Fecal-based antimicrobial resistance gene testing overcomes these barriers, offering distinct advantages of being non-invasive, rapid and accurate, thereby improving patient compliance. This study aims to elucidate the diagnostic value of fecal nucleic acid testing for H. pyloriinfection and to evaluate the eradication rate and safety of tailored triple therapy regimens selected based on fecal resistance gene profiles.
Official title: Multicenter, Randomized Controlled Study on Personalized Rescue Treatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
531
Start Date
2026-05-12
Completion Date
2027-02-01
Last Updated
2026-04-16
Healthy Volunteers
No
Interventions
Personalized treatment based on the results of fecal antimicrobial resistance gene testing
Personalized treatment: Patients sensitive to clarithromycin are assigned to the Clarithromycin Group (receiving a regimen of vonoprazan, amoxicillin, and clarithromycin); Patients resistant to clarithromycin but sensitive to levofloxacin are assigned to the Levofloxacin Group (receiving vonoprazan, amoxicillin, and levofloxacin); Patients resistant to both clarithromycin and levofloxacin are assigned to the Tetracycline Group (receiving vonoprazan, amoxicillin, and tetracycline). The treatment duration for all groups is 10 days. The specific dosages and administration methods are as follows: Vonoprazan: 20 mg, twice daily (BID) Amoxicillin: 1.0 g, twice daily (BID) Clarithromycin: 0.5 g, twice daily (BID) Levofloxacin: 0.5 g, once daily (QD) Tetracycline: 0.5 g, three times daily (TID)
Conventional Quadruple Therapy
Conventional Quadruple Therapy： Vonoprazan 20mg BID; Colloidal Bismuth Pectin 220mg BID; Amoxicillin 1.0g BID; tetracycline 0.5g TID. Treatment duration: 14 days.