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临床试验/NCT01863823
NCT01863823已完成1 期

Director of Research Division

Ameritek USA1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
350
试验地点
1
主要终点
Success Rate

研究概览

简要总结

  1. Gastric eradication has no effective on oral H. pylori infection.
  2. Treatment of oral infection increase success rate of eradication on stomach infection.

详细描述

Objective

The present study was aimed to explore the relationship of Helicobacter pylori(H. pylori) of the oral cavity with the success rate eradication of gastric H. pylori infection.

Study Design and Setting: 202 symptomatic and 148 asymptomatic individuals were recruited and tested using Saliva H. pylori antigen tests (HPS), H. pylori flagellin (HPF), the urea breathe test (UBT) and the polymerase chain reaction (PCR) test. Test subjects also received various treatments.

We collected data of HPS, HPF , PCR and UBT before treatment on 202 symptomatic patients and 148 asymptomatic individual groups. After drug treatment, we run HPS, HPF, PCR and UBT tests. If the tests of HPS, HPF and PCR show negative that indicate success of oral H.pylori eradication. If the test of UBT show negative that indicate success of stomach H.pyloi eradication. We also compare the suceess rate of eradication on stomach infection with and without oral H. pylori infection.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with gastrointestinal complaints

排除标准

  • patients who had taken any antibiotics and/or proton pump inhibitors within four weeks prior to sample collection

研究组 & 干预措施

Amoxicillin and Tetracyclines

Other

drug treatment

干预措施: Amoxicillin and Tetracyclines (Drug)

Mouth washing

Other

Mouth washing

干预措施: Mouth washing (Drug)

结局指标

主要结局

Success Rate

时间窗: 12 months

次要结局

  • Diagnostic(6 months)

研究者

发起方
Ameritek USA
申办方类型
Industry
责任方
Principal Investigator
主要研究者

K C Yee

Director of Research Division

Ameritek USA

研究点 (1)

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