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临床试验/NCT01301131
NCT01301131Unknown4 期

Randomized Controlled Trial of Fermented Dairy Product Containing L. Casei Shirota for Prevention of Ventilator-Associated Pneumonia

Mahidol University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
4 期
入组人数
150
试验地点
2
主要终点
Number of subjects with pneumonia

研究概览

简要总结

Hospitalized patients with ventilator are randomized to receive fermented dairy product containing L. casei shirota or nothing. The main outcome is development of ventilator-associated pneumonia (VAP)

详细描述

Fermented dairy product containing L. casei shirota has bee shown to inhibit multi-drug-resistant bacteria. This study is conducted to determine if Fermented dairy product containing L. casei shirota can prevent ventilator-associated pneumonia.

研究设计

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

入排标准

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

入选标准

  • Patient age ≥ 18-year who received ventilator and agreed to participate by signing informed consent form

排除标准

  • Immunocompromised host (e.g. HIV infection, On immunosupressive agents, ANC ≤ 500 cell/ml), Pregnancy, History of congenital heart disease, rheumatic fever, previously infective endocarditis, prosthetic valve, Contraindication for enteral feeding, History of milk or milk-product allergy

结局指标

主要结局

Number of subjects with pneumonia

时间窗: up to 28 days

patient with pneumonia

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

Visanu Thamlikitkul

Faculty of Medicine Siriraj Hospital

Mahidol University

研究点 (2)

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