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临床试验/NCT04186949
NCT04186949已完成不适用

Early Origins of Allergy and Asthma

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 273 人开始时间: 2018年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
273
试验地点
1
主要终点
Development of allergic diseases in offspring

研究概览

简要总结

Birth cohort study with recruitment during pregnancy to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases, asthma, and metabolic conditions in the offspring.

详细描述

Despite recent advances in the understanding of the pathogenesis of allergies and asthma, these diseases still have no clear preventative measures or curative treatments. Growing evidence shows that atopic dermatitis (AD), food allergy (FA), allergic rhinitis, and asthma are largely determined during the first 1000 days (time elapsed from conception to the 2nd birthday). This cohort aims to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases, and asthma in the offspring.

The investigators have designed a birth cohort of 250 families with recruitment in pregnancy (~14 weeks). The plan is to genotype relevant allergy/asthma-associated variants and will perform immunophenotyping and evaluation of allergy biomarkers in cord blood. At 2 years of age the investigators will assess if infants have developed allergic sensitization, AD, FA, as well as biomarkers of asthma including the asthma predictive index. The study will also evaluate how maternal conditions modify immune programming through epigenetic modifications, and will then confirm newborn epigenetic cues of allergy/asthma risk. Next, the investigators will assess composition/diversity of maternal gut, placenta, breastmilk and infant gut microbiome and their association with immunophenotype and biomarkers at birth, and clinical outcomes at age 2. Finally, another specific objective is to assess how environmental exposures (perinatal outdoor and indoor pollution, endotoxin and allergens) affect the incidence of allergic sensitization, AD, FA, and risk of asthma.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Pregnant women living in Chile's central regions
  • Offspring of women recruited in the cohort study

排除标准

  • 未提供

结局指标

主要结局

Development of allergic diseases in offspring

时间窗: 2 years

Atopic dermatitis, food allergy, allergic sensitization, predicted increased risk of asthma

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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