drugset / Trial / NCT07533422

Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing

NCT07533422

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-05-12
Primary completion
2026-12-30
Completion
2027-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 0.5 g
Subject Levofloxacin Small molecule 0.5 g
Comparator Tetracycline Unknown 0.5 g
Comparator colloidal bismuth pectin Unknown 220 mg
Comparator Amoxicillin Other / unclassified 1 g
Comparator Vonoprazan Other / unclassified 20 mg