The Association Between Human Milk Oligosaccharide and Development of Allergic Manifestations in Infants
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Atopic dermatitis
研究概览
简要总结
Compare the HMO composition in breast milk of infants with allergic manifestation (atopic dermatitis and food allergy) in the first 3 years of life, healthy infants with allergic mother and healthy infants with non-allergic mother.
详细描述
- Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project
- After completed informed consent, demographic data was collected and filled in case record form
- Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis
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
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mothers with breast-fed infant with or without allergic manifestation
- •Intend to participate for follow up and sign consent to participate in the study
排除标准
- •Mothers with any medical illness or high risk infant pregnant
- •Infants with disease which affected allergic disease
- •No inform consent
- •Anything in the opinion of the investigator that would prevent children from completing the study
结局指标
主要结局
Atopic dermatitis
时间窗: first 2 years of life
Relapsing eczematous typical morphology on typical distribution (Scalp, face, neck, and extensor surfaces of the skin) Typical morphology Acute and subacute : erythematous papules and plaques, may vesiculate and become exudative Chronic : lichenification, papules and excoriations
IgE mediated food allergy
时间窗: first 2 years of life
confirmed by oral food challenge
Non-IgE mediated food allergy
时间窗: first 2 years of life
Presentation of clinical ex. bloody stool when repeating episode occurred with the same food more than twice. Improvement of symptom after eliminating of suspected food
次要结局
未报告次要终点