临床试验/NCT07285096

NCT07285096招募中不适用

Efficacy and Safety of P-CABs-Based Bismuth Quadruple Therapy for First-line Helicobacter Pylori Eradication: A Multicenter Cohort Study

Yueyue Li1 个研究点分布在 1 个国家目标入组 1,730 人开始时间: 2025年12月16日最近更新: 2025年12月23日

适应症

试验速览

阶段: 不适用
状态: 招募中
发起方
入组人数: 1,730
试验地点: 1
主要终点: Eradication rate

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Bismuth-containing quadruple therapy was recommended as a first-line treatment for Helicobacter pylori infection. This study aimed to compare real-world outcomes of various potassium-competitive acid blockers (P-CABs) -based bismuth quadruple regimens and identify factors influencing treatment failure. A multicenter cohort study was conducted and study outcomes included eradication rates and incidence of adverse events.

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 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•patients aged 18-70 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 who received treatment regimens that did not comply with the quadruple regimens specified in this study.

结局指标

主要结局

Eradication rate

时间窗: 6-8 weeks after treatment completion

Comparison of eradication rates among quadruple therapies for Helicobacter pylori

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

Associate Professor

Qilu Hospital of Shandong University

研究点 (1)

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