Human Milk and Infant Intestinal Microbiome Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Skin-to-skin contact
研究概览
简要总结
This study will explore the effects of skin-to-skin contact (SSC) between mothers and their babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk microbiome. This will be accomplished by administering an intervention education session to one group and a placebo education session to the second group in order to influence the magnitude of total SSC defined by the frequency and duration of contact time between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pregnant women scheduled to deliver at the University of Virginia Health System
- •Women 18 years or older and their newborn infant
- •Stated intent to exclusively breastfeed for the duration of post-partum hospital admission
- •To have physical custody of their child when they are discharged from the hospital
排除标准
- •Maternal antibiotic use in the 3 months prior to delivery
- •Consumption of alcohol in the 3 months prior to delivery
- •Recreational drug use in the 3 months prior to delivery
- •Serious gastrointestinal conditions requiring medical intervention or medication during pregnancy (e.g. Crohn's disease, ulcerative colitis, celiac disease, gastrointestinal infections)
- •Serious health conditions that require medication during pregnancy
研究组 & 干预措施
Intervention education
Participants will receive the intervention education and data recording package.
干预措施: Intervention education (Other)
Placebo education
Participants will receive the placebo educational and data recording package.
干预措施: Placebo Education (Other)
结局指标
主要结局
Skin-to-skin contact
时间窗: Duration of hospital admission after delivery (2-3 days)
Self-reported magnitude of maternal-infant skin-to-skin contact
次要结局
- Maternal dietary intake(During pregnancy)
- Maternal skin microbiome(Duration of hospital admission after delivery (2-3 days))
- Maternal breast milk microbiome(Duration of hospital admission after delivery (2-3 days))
- Infant intestinal microbiome(Duration of hospital admission after delivery (2-3 days))
研究者
Joann McDermid
Joann M. McDermid, MSc, PhD, RDN
University of Virginia