Effects of Breastfeeding in Immunologic Priming in Young Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 3
- 主要终点
- Molecular profile of human IgG and IgA by pyrosequencing.
研究概览
简要总结
This study will follow 40 healthy, vaginally delivered infants that are primarily (>/- 75%) breast fed and 40 infants that are exclusively formula fed for at least the first 4 months of life from birth until 12 month age. Visits - Subjects will be consented prior to delivery, visit 1. Subject will be seen if possible after delivery for instruction on stool collection and distribution of supplies, visit 2. Subject will be seen at 6 months of age post immunization, visit 3. Subject will be seen prior to 12 month visit. Study staff will contact via phone/email to collect information about feeding changes.
详细描述
Cord Blood will be collected at birth if possible and peripheral blood will be collected at 6 month of age (5 to 10 days after receiving their standard 6 month immunizations) and at 12 months of age prior to their 12 month immunization. Additionally, stool samples will be collected within the first week of live and once monthly through 12 months of age. Breastfeeding mothers will collect breast milk once monthly at the same time as the stool specimen during the period of breastfeeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Self-declared pregnant woman
- •Age 18 years or older at the time of consent
- •Willing and able to sign consent and follow study schedule
- •Planned vaginal delivery
- •Willing to primarily breastfed or formula feed for the first four months
排除标准
- •Planned delivery by C-Section
- •Unwillingness to exclusively breast feed or formula feed their infant for at least the first 4 months
- •Unwillingness to receive standard immunizations on the schedule recommended by the American Academy of Pediatrics
- •Chronic maternal condition that may influence infant immunity including but not limited to: maternal HIV, immunodeficiency, use of immunosuppressive medications, malignancy or autoimmunity
- •Known fetal medical conditions such as congenital malformations
- •Use of immune modulating/immune suppressive medication and prophylactic antibiotics during pregnancy
- •Any condition that may prevent a mother who plans to breast feed from breast feeding
- •Any condition that in the opinion of the investigator would interfere with the conduct of the study
结局指标
主要结局
Molecular profile of human IgG and IgA by pyrosequencing.
时间窗: 12 months
B cell priming and immunoglobulin diversity following immunizations at 2 and 4 month of age by modulating the microbial colonization of infant gut by pyrosequencing by using isotype specific primers.
次要结局
- Vaccine response(12 months)
- Plasma level of B cell activating factor and/or a proliferation-inducing ligand(12 months)
- Antibody activity(12 months)