Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized treatment based on the results of fecal antimicrobial resistance gene testing, Conventional Quadruple Therapy.
- Who it may be relevant to
- Registry conditions: HELICOBACTER PYLORI INFECTIONS, Rescue Therapy for Helicobacter Pylori. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter, Randomized Controlled Study on Personalized Rescue Treatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
Overview
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.
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 treatmen - 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.
Primary outcome measures
- H. pylori eradication rate [Time frame: From enrollment to the end of treatment at 6 weeks]
Secondary outcome measures (1)
- Adverse effect of the treatment [Time frame: From enrollment to the end of treatment at 6 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07533422 · 2025-1670