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临床试验/NCT07374822
NCT07374822已完成不适用

Study on the Real-World Eradication Success Rate of Helicobacter Pylori Infection and Its Influencing Factors

Run-hua Li1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年5月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,000
试验地点
1
主要终点
H. pylori Eradication Success Rate

研究概览

简要总结

This study aims to evaluate the real-world effectiveness of different treatment regimens used to eradicate Helicobacter pylori (H. pylori) infection in routine clinical practice. H. pylori is a common bacterial infection that can lead to chronic gastritis, peptic ulcers, and gastric cancer. Treatment success varies widely in real-world settings due to factors such as antibiotic resistance, patient characteristics, and treatment adherence.

This retrospective observational study will review medical records of patients who underwent H. pylori testing and/or eradication treatment at Shenzhen Hospital of Southern Medical University between 2016 and 2023. No additional tests, visits, or interventions will be performed beyond standard clinical care. The study will collect information on demographics, comorbidities, treatment regimens, test results, and eradication outcomes.

The primary goal is to determine the real-world eradication success rate of commonly used treatment regimens. A secondary goal is to identify factors that may influence treatment effectiveness. Findings from this study may help clinicians choose more effective treatment strategies and improve patient outcomes in everyday clinical practice.

研究设计

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

入排标准

年龄范围
14 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 14 years.
  • Patients who underwent Helicobacter pylori (H. pylori) testing and/or eradication treatment at Shenzhen Hospital of Southern Medical University between 2016 and
  • Diagnosis of H. pylori infection based on the Sixth National Consensus Report on the Management of Helicobacter pylori Infection (Non-Eradication Section) or clinically accepted testing methods.

排除标准

  • Children younger than 14 years old.
  • Pregnant or breastfeeding women.
  • Patients deemed unsuitable for participation by the investigator based on clinical judgment.

研究组 & 干预措施

Patients With Helicobacter pylori Infection

Participants who underwent H. pylori testing and/or eradication treatment at Shenzhen Hospital of Southern Medical University between 2016 and 2023.

This cohort includes patients receiving different eradication regimens as part of routine clinical care. No study-assigned interventions are provided.

干预措施: No Study-Assigned Intervention (Other)

结局指标

主要结局

H. pylori Eradication Success Rate

时间窗: Within 4-12 weeks after completion of eradication therapy

The proportion of patients who achieve successful eradication of Helicobacter pylori, as confirmed by a urea breath test (C13), stool antigen test, histology, or other clinically accepted diagnostic methods. Eradication success is defined as a negative post-treatment test result.

次要结局

未报告次要终点

研究者

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

Run-hua Li

Clinical Physician and Principal Research Investigator

Shenzhen Hospital of Southern Medical University

研究点 (1)

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