Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
Starting soon · Not applicable
Conditions studied: HELICOBACTER PYLORI INFECTIONS, Rescue Therapy for Helicobacter Pylori
In brief
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.
Key facts
- Study ID
- NCT07533422
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 531
- Starts
- 2026-05-12
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ① Age 18-70 years;
- Patients with Hp-positive chronic gastritis who have failed initial treatment, as confirmed by urea breath test or endoscopic biopsy;
- No use of PPIs, H2-receptor antagonists, antibiotics, or bismuth agents within 4 weeks;
- History of having received one previous, standardized Hp eradication therapy.
You may not qualify if…
- ① Use of antibiotics, bismuth agents within 4 weeks prior to treatment, or use of PPIs or H₂-receptor antagonists within 2 weeks prior to treatment;
- History of gastric or duodenal surgery;
- Concurrent presence of other serious conditions such as cardiac, hepatic, or renal dysfunction, malignant tumors, or other severe internal diseases;
- Allergy to any component of the study medications; ⑤ Pregnant or breastfeeding women; ⑥ Participation in other drug studies within 3 months prior to treatment; ⑦ Patients unable to accurately express their complaints or cooperate with the study investigators.
Full record on ClinicalTrials.gov
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