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临床试验/NCT02674802
NCT02674802Unknown不适用

Reinfection After Eradication of Helicobacter Pylori Infection in Adult :A National Multicentre Study

The First Affiliated Hospital of Nanchang University1 个研究点 分布在 1 个国家目标入组 3,500 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,500
试验地点
1
主要终点
Helicobacter Pylori Infection

研究概览

简要总结

Helicobacter pylori is closely related with gastritis, peptic ulcer, gastric cancer and gastric MALT lymphoma, and it may participate in a variety of parenteral diseases. Infection rates of Helicobacter pylori is still high, so effectively eradication is necessary. At present, the eradication therapy has achieved very good curative effect. However, relapse after eradication is unoptimistic. This study has made an analysis for reinfection after eradication of Helicobacter pylori Infection include the retrospective and prospective studies, aims to explore the epidemiological data and related risk factors of Hp reinfection in China.

详细描述

In the retrospective study,we choose the people received regular eradication therapy, successfully eradicated helicobacter pylori more than six months, but 4 to 8 weeks after drug withdrawal ,the detection result of helicobacter pylori were negative to ensure that the results of the study is the reinfection, not residual. Even more noteworthy is during the treatment and detection again, the patients must not received any eradication therapy of Hp. What's more , before the detection, they also has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks to prevent affecting the accuracy of the results. At the same time, we also investigated the patient's general situation, conomic conditions, living conditions, personal health and lifestyle to explore related risk factors of Hp reinfection in China. In the prospective study, we detected Hp by C-UBT after regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months to prospect the reinfection of Hp.It also can make up the defects of retrospective study.

研究设计

研究类型
Observational

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

入选标准

  • 1、Retrospective study:
  • Received regular eradication therapy, 4 to 8 weeks after drug withdrawal , detected of helicobacter pylori and the results were negative
  • Eradication program and original disease is unlimited
  • Without any eradication therapyof Hp during the treatment and detection again
  • before the detection has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks.
  • 2、Prospective study
  • Infected with H. pylori that detected by C-UBT
  • With out alimentary tract hemorrhage,ulceration and complications of eradication
  • Eradication program and original disease is unlimited

排除标准

  • Pregnancy or breast-feeding women
  • With the major disease which would influence the research such as liver disease, heart disease, kidney disease, malignant tumor and alcohol poisoning
  • Participated in other drug research in the past three months
  • The patient can't express himself correctly such as mental illness and severe neurosis and can't cooperation this test

结局指标

主要结局

Helicobacter Pylori Infection

时间窗: After regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months

Prospective study

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lingyu Luo

Physician-in-charge

The First Affiliated Hospital of Nanchang University

研究点 (1)

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