跳至主要内容
临床试验/NCT04030715
NCT04030715Unknown不适用

The Associations Between the Gastric Mucosal Pathology and the Eradication Rate of H.Pylori :A Multicenter Study

Shandong University1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2018年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
1,200
试验地点
1
主要终点
Eradication Rate of H.Pylori

研究概览

简要总结

Use the two-categorical variable , eradicate success or failure ,as a dependent variable, and analyze the influential factors by logistic regression.And then the statistically significant influencing factors like gastric mucosal pathology are obtained.We build a predictive model of the outcome of Hp eradication therapy based on significant influencing factors. The difference with p 0.05 is statistically significant.

详细描述

The subjects who are naiive Hp infection patients recieved the Hp eradication therapy based on antimicrobial susceptibility test.Using success or failure of eradication as a dependent variable, analyze the influential factors by logistic regression.And then the statistically significant influencing factors like gastric mucosal pathology are obtained.We build a predictive model of the outcome of Hp eradication therapy based on significant influencing factors. The difference with p<0.05 is statistically significant.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Other
盲法
None

盲法说明

no masking

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 between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

排除标准

  • •Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, patient with peptic ulcer, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

研究组 & 干预措施

the successful group

Other

divide the subject to two groups based on the success or failure of eradication, and analyze the influential factors of eradication. Build a predictive model for the success of eradication.

干预措施: bismuth-containing quadral therapy based on antibiotic susceptibility (Drug)

the failure group

Other

divide the subject to two groups based on the success or failure of eradication, and analyze the influential factors of eradication. Build a predictive model for the success of eradication.

干预措施: bismuth-containing quadral therapy based on antibiotic susceptibility (Drug)

结局指标

主要结局

Eradication Rate of H.Pylori

时间窗: 2months

evaluate the eradication rate of H.Pylori and analysis the association between the gastric mucosal pathology and the eradication rate

次要结局

未报告次要终点

研究者

发起方
Shandong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiuli Zuo

director of Qilu Hospital gastroenterology department

Shandong University

研究点 (1)

Loading locations...

相似试验