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临床试验/NCT00113659
NCT00113659已完成不适用

Trial of Infant Probiotic Supplementation to Prevent Asthma

Montefiore Medical Center2 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
2
主要终点
Development of atopic dermatitis

研究概览

简要总结

The goal of the study is to understand the mechanisms of how antigen presentation affects the developing immune system and subsequently affects susceptibility to, or protects against, asthma development. This randomized controlled study will test the effectiveness of daily supplementation of Lactobacillus GG for the first 6 months of life on the early immunological development of asthma.

详细描述

BACKGROUND:

During infancy, environmental factors may affect immune system development and lead to the development of asthma. The hygiene hypothesis suggests that the absence of endotoxin exposure leads to an unfavorable Th1/Th2 balance. Thus, a controlled antigen exposure during infancy may establish a Th1/Th2 balance that blocks the onset of asthma or slows the progression of the disease.

Lactobacillus is a bacterium commonly found in many foods (e.g., yogurt) in the typical childhood diet. It is also used as a probiotic supplement to prevent the development of diarrhea. Due to its safety and availability, Lactobacillus is an ideal bacterium to use as an antigen exposure to test the hygiene hypothesis.

Consistent with the hygiene hypothesis, observational studies suggest that early Lactobacillus exposure leads to decreased risk of developing atopic dermatitis, which has been associated with asthma in later years. The investigators are aware of no study that has examined the effect of Lactobacillus on the development of early markers of asthma in children at risk for developing the disease. They hypothesize that Lactobacillus can be used as an antigen exposure to establish a Th1/Th2 balance that blocks the development of early markers of asthma.

DESIGN NARRATIVE:

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
1 Day 至 4 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Development of atopic dermatitis

时间窗: Measured from birth to 3 years of age

次要结局

  • Early clinical markers of asthma, including frequent wheezing, wheezing without upper or lower respiratory tract infections, allergic rhinitis, atopic dermatitis, serum IgE, and eosinophilia(Measured from birth to 3 years of age)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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