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临床试验/JPRN-UMIN000045892
JPRN-UMIN000045892已完成未知

Clinical study on the efficacy of H. pylori molecular diagnostic kit. Testing with stool and gastric wash waste. - Clinical study on the efficacy of H. pylori molecular diagnostic kit. Testing with stool and gastric wash waste.

MIZUHO MEDY Co., Ltd.0 个研究点目标入组 143 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
143

研究概览

简要总结

For H. pylori molecular diagnostic kit using gastric wash waste, concordance ratio compared with H. pylori conventional diagnostic method were 93.6% for urea breath test, 93.2% for stool antigen test and 97.9% for culture. And concordance rate with clarithromycin antibiotic susceptibility test was 97.0%. For H. pylori molecular diagnostic kit using stool, sensitivity compared with stool antigen test was 84.2%. And concordance rate with clarithromycin antibiotic susceptibility test was 100%.

研究设计

研究类型
Observational

入排标准

年龄范围
15years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • Patients who meet any of the following conditions (1) Patients who did not obtain sufficient samples for the study (2) Patients who have already received H. pylori eradication treatment (3) Patients with serious disabilities (4) Pregnant or potentially pregnant patients (5) Other patients who the attending physician has determined to be unable to participate in the study

研究者

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