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临床试验/NCT04835935
NCT04835935进行中(未招募)不适用

The Association Between Milk Feedings in the Preterm Population, the Microbiome and Risk of Atopic Disease

Sydney Leibel2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
51
试验地点
2
主要终点
Pediatric Atopic Disease

研究概览

简要总结

There is increasing recognition that the microbiome may be important in the development of allergic disease. Asthma is the most prevalent pediatric chronic disease and affects more than 300 million people worldwide. For unclear reasons, those infants born at 34 weeks and earlier are three times as likely to develop asthma. Factors such as formula feeding, C-section delivery and antibiotic exposure may play a role. Recent evidence has identified a "critical window" in early life where gut and breast milk microbial changes are most influential. The investigators propose a novel study to follow a cohort of premature babies in the NICU and after discharge home. The investigators aim to examine whether various exposures of babies in the NICU impact their milk and gut microbiome and lead to asthma and allergies.

Our specific aims are:

  1. To assess if there is a specific pattern of gut and/or breast milk microbiome over time that is affected by the type of nutrition a baby receives (donor vs maternal vs formula) or other exposures such as antibiotics.
  2. Assess whether there are patterns in the microbiome associated with the development of allergic sensitization patterns.
  3. Determine if early patterns of the microbiome and allergic sensitization predict allergic conditions (food allergies, allergic rhinitis, eczema, asthma) by 2 years of age.

The investigators will recruit approximately 50 subjects born at 34 weeks of gestation or earlier from two local level III NICU. These subjects will be followed over their NICU course with weekly stool, milk feed, and oral saliva collection as well as documentation of relevant events including prenatal history, delivery history, nutrition and breast feeding history and antibiotic courses. Further samples will be collected after discharge at research visits that will take place Rady Children's Hospital until 4-6 years of age. At these visits, standardized allergy questionnaires and a blood allergy panel will be obtained. Together this data will provide a unique opportunity to identify potential shifts in the microbiome associated with nutrition, asthma and allergy in preterm infants. Ultimately, the investigators may be able to discover ways to prevent the development of asthma and allergies during this early window of opportunity.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
0 Days 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • premature infant equal or less than 34 weeks of age

排除标准

  • hypoxic ischemic encephalopathy, congenital anomaly that affects gastrointestinal system, unable to follow up

结局指标

主要结局

Pediatric Atopic Disease

时间窗: 2-3 years of age

Clinical diagnosis of any atopic disease among the participants during study follow up visit. These include any food allergies, allergic rhinitis, eczema, and asthma.

次要结局

  • Allergic sensitization patterns(1-2 years)

研究者

发起方
Sydney Leibel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sydney Leibel

Assoc Physician

University of California, San Diego

研究点 (2)

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