跳至主要内容
临床试验/NCT02761005
NCT02761005Unknown2 期

Eradication of H. Pylori With the Regimen Individualized Susceptibility of H. Pylori to Clarithromycin Determined by the Mutation of 23S rRNA of H. Pylori

Hamamatsu University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
100
试验地点
1
主要终点
Eradication rates

研究概览

简要总结

Patients infected with H. pylori are treated with the individualized regimen which is based on the mutation of 23S rRNA of H. pylori.

详细描述

Patients infected with H. pylori undergo the gastroscopy. During the gastroscopy, gastric mucus samples are collected, from which DNA is extracted. The DNA samples are subjected the full-auto SNP analyzer and the from A to G mutation of 23s rRNA of H. pylori at the positions of 2142 and 2143 is measured. When the mutation is detected, patients are diagnosed to be infected with clarithromycin-resistant strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + metronidazole 250 mg bid for 1 week. When the mutation is not detected, patients are considered to be infected with clarithromycin-sensitive strains of H. pylori and therefore, treated with the triple therapy with vonoprazan 20 mg bid + amoxicillin 750 mg bid + clarithromycin 200 mg bid for 1 week. The success or failure of eradication was determined based on the 13C-urea breath test performed 1 month after the therapy. The total eradication rates with this strategy was compared with that by the standard regimen in Japan performed in the same period of the study.

研究设计

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

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients infected with H. pylori are invited to the study.
  • Patients not allergic to the any of the drugs used for eradication of H. pylori.
  • Patients who has agreed to participate to the study.

排除标准

  • Patients allergic to the any of the drugs used for eradication of H. pylori.
  • Patients who do not agree to the study.

研究组 & 干预措施

23S rRNA wt

Experimental

As the 23S rRNA mutation guided selection of antimicrobial agent, patients infected with strains without mutation of 23S rRNA are assigned to this arm. In this arm, they are treated with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg bid for 1 week for the eradication of H. pylori.

干预措施: Eradication of H. pylori (Drug)

23S rRNA mutation

Experimental

As the 23S rRNA mutation guided selection of antimicrobial agent, patients infected with strains with mutation of 23S rRNA are assigned to this arm. In this arm, they are treated with vonoprazan 20 mg bid, amoxicillin 750 mg bid and metronidazole 250 mg bid for 1 week for the eradication of H. pylori,

干预措施: Eradication of H. pylori (Drug)

结局指标

主要结局

Eradication rates

时间窗: Eradication of H. pylori is measured 1 month after the therapy

次要结局

未报告次要终点

研究者

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

Takahisa Furuta

Professor

Hamamatsu University

研究点 (1)

Loading locations...

相似试验

Eradication of H. Pylori Therapy Individualized by... | 临床试验