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临床试验/NCT07335406
NCT07335406尚未招募不适用

Registry for the Management of Helicobacter Pylori Infection in Shandong Province

Yueyue Li2 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10,000
试验地点
2
主要终点
Eradication rate

研究概览

简要总结

Helicobacter pylori infection is a common global gastrointestinal infectious disease, affecting approximately 43.1% of the world's population. Eradicating H. pylori is crucial for reducing the risk of developing conditions such as gastritis, peptic ulcer disease, and gastric cancer. Currently, 14-day high-dose dual therapy containing amoxicillin and bismuth-containing quadruple therapy are the guideline-recommended first-line treatment regimens for H. pylori eradication. Treatment options for H. pylori vary considerably, with differing efficacy outcomes largely attributable to increasing bacterial antibiotic resistance. Furthermore, multiple factors influence the efficacy of H. pylori eradication, including smoking, body surface area, CYP2C19 gene polymorphisms, patient compliance, and regional variations.

Therefore, to systematically evaluate the efficacy and safety of different treatment regimens alongside the cost-effectiveness of various therapeutic strategies, and to conduct ongoing critical analysis of clinical practice, this study proposes a long-term investigation of real-world clinical practice through a non-interventional cohort study registry. This will assess the effectiveness, safety, and temporal trends of different H. pylori infection treatment regimens, providing real-time evidence to support clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients aged 18-80 years, regardless of gender;
  • willing to receive H. pylori eradication therapy;
  • diagnosed with H. pylori infection through at least one of the following methods: rapid urease test, ¹³C/¹⁴C-urea breath test, or histopathological examination.

排除标准

  • patients with incomplete medical records, including missing treatment details, absence of post-treatment follow-up test results, or failure to complete essential follow-up assessments;
  • patients with severe underlying conditions such as hepatic insufficiency, renal insufficiency, or malignant tumours;
  • pregnant or breastfeeding women;
  • individuals who refuse to sign the informed consent form

结局指标

主要结局

Eradication rate

时间窗: at least 6 weeks after treatment completion

次要结局

  • Adverse events(lmmediately after treatment completion)

研究者

发起方
Yueyue Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yueyue Li

Clinical Professor

Qilu Hospital of Shandong University

研究点 (2)

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