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临床试验/NCT05173493
NCT05173493已完成不适用

The Study About the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure

Shandong University1 个研究点 分布在 1 个国家目标入组 670 人开始时间: 2021年12月30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
状态
已完成
发起方
入组人数
670
试验地点
1
主要终点
The most suitable re-eradication time

研究概览

简要总结

The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

详细描述

Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer. At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment inpatients with Hp eradication failure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients aged 18-70 with H. pylori infection.
  • Patients with previous Helicobacter pylori eradication.

排除标准

  • Patients treated with H2-receptor antagonist, PPI, bismuth and antibioticsin the previous 4 weeks.
  • Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
  • Patients with known or suspected allergy to study medications.
  • Currently pregnant or lactating.
  • Inability to provide informed consent and other situations that couldinterfere with the examination or therapeutic protocol.

研究组 & 干预措施

Amoxicillin-Levofloxacin-containing quadruple group

Patients in amoxicillin-Levofloxacin-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), amoxicillin1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and levofloxacin 500mg po qd for 14d.

干预措施: Amoxicillin,Levofloxacin (Drug)

Amoxicillin-Furazolidone-containing quadruple group

Patients in amoxicillin-furazolidone-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), amoxicillin1000mg po bid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

干预措施: Amoxicillin,Furazolidone (Drug)

Tetracycline-Furazolidone-containing quadruple group

Patients in tetracycline-furazolidone-containing quadruple group will receive esomeprazole (Nexium) 40mg po bid(or vonoprazan fumarate 20mg po bid), tetracycline 500 mg po qid, bismuth potassium citrate(Lizhudele) 220mg po bid, and furazolidone (Liteling) 100mg po bid for 14d.

干预措施: Tetracycline,Furazolidone (Drug)

结局指标

主要结局

The most suitable re-eradication time

时间窗: 6 months

The most suitable re-eradication time(The unit is month) will be assessed by paired comparison method .

次要结局

  • Eradication rates in three groups(6months)

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

Professor, Director of gastroenterology department of Qilu hospita

Shandong University

研究点 (1)

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