NCT07533422

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

Multicenter, Randomized Controlled Study on Personalized Rescue Treatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 531 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma, and is classified as a Group I carcinogen by the World Health Organization. The "2022 Chinese Clinical Guidelines for the Treatment of Helicobacter pyloriInfection" 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 (no endoscopy required), rapid (significantly shorter turnaround time), and accurate (direct detection of resistance genes), 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.

Conditions

• HELICOBACTER PYLORI INFECTIONS
• Rescue Therapy for Helicobacter Pylori

Interventions

Type	Name	Description
DRUG	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)
DRUG	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.

Timeline

• Start date: 2026-05-12
• Primary completion: 2026-12-30
• Completion: 2027-02-01
• First posted: 2026-04-16
• Last updated: 2026-04-16