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

NCT07533422 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 531

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • HELICOBACTER PYLORI INFECTIONS
  • Rescue Therapy for Helicobacter Pylori

Interventions

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07533422 on ClinicalTrials.gov