Multicenter, Randomized Controlled Study on Personalized Rescue Treatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 531
- 主要终点
- H. pylori eradication rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
干预措施: Conventional Quadruple Therapy (Drug)
Experimental group
干预措施: Personalized treatment based on the results of fecal antimicrobial resistance gene testing (Drug)
结局指标
主要结局
H. pylori eradication rate
时间窗: From enrollment to the end of treatment at 6 weeks
次要结局
- Adverse effect of the treatment(From enrollment to the end of treatment at 6 weeks)