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临床试验/NCT04415983
NCT04415983招募中3 期

Study of Novel Triple Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori in Children

Tanta University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
招募中
入组人数
100
试验地点
1
主要终点
Number of patients with cured helicobacter infection

研究概览

简要总结

Study of Nitazoxanide (NTZ) based therapeutic regimens for Helicobacter pylori in children

详细描述

Study of Novel triple Nitazoxanide (NTZ) based new therapeutic regimens for Helicobacter pylori in children

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Positive helicobacter infection.

排除标准

  • Previous treatment for H. Pylori.

研究组 & 干预措施

Nitazoxanide group

Experimental

Clarithromycin, Nitazoxanide and Proton pump inhibitor

干预措施: Nitazoxanide (Drug)

Nitazoxanide group

Experimental

Clarithromycin, Nitazoxanide and Proton pump inhibitor

干预措施: Clarithromycin (Drug)

Nitazoxanide group

Experimental

Clarithromycin, Nitazoxanide and Proton pump inhibitor

干预措施: Proton pump inhibitor (Drug)

Traditional group

Active Comparator

Clarithromycin, Metronidazole and Proton pump inhibitor

干预措施: Clarithromycin (Drug)

Traditional group

Active Comparator

Clarithromycin, Metronidazole and Proton pump inhibitor

干预措施: Metronidazole (Drug)

Traditional group

Active Comparator

Clarithromycin, Metronidazole and Proton pump inhibitor

干预措施: Proton pump inhibitor (Drug)

结局指标

主要结局

Number of patients with cured helicobacter infection

时间窗: 6 months

Total number of patients with eradicated helicobacter infection

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Tanta University

研究点 (1)

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