Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Microbiome outcome
研究概览
简要总结
The investigators will be studying the development of the microbiome over the first year after birth in light of various environmental influences - e.g. mode of delivery, diet (and diet changes), antibiotic exposure, GERD medication exposure.
详细描述
Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay through the first year of life. Investigators will perform statistical analyses to test the hypotheses (1) that there is an association between the developing oral and gut microbiomes, and (2) that they interact in affecting childhood obesity.
This study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring oral and gut microbiome collected from that study's second born participants.
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
- 是
入选标准
- •full-term infant (> 36 0/7 weeks gestational age) without significant morbidity
- •nursery/NICU/maternity stay of 7 days or less
- •participant children can be (but do not have to be) twins
- •English speaking mother
- •care provided at an HMC affiliated clinic
- •a working telephone number
排除标准
- •prenatal ultrasound presence of intrauterine growth retardation (IUGR)
- •infant birth weight <2250 grams
- •presence of a congenital anomaly or neonatal condition that significantly affects a newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)
- •any major maternal morbidities and/or pre-existing condition that would affect postpartum care or her ability to care for her newborn such as cancer, multiple sclerosis, lupus, etc.
- •plan for newborn to be adopted
- •plan to move from Central Pennsylvania within 1 year
- •have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary study)
结局指标
主要结局
Microbiome outcome
时间窗: birth to 1 year
Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals
次要结局
- Genetic variation(birth to 1 year)
研究者
Ian M. Paul, MD
Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics
Milton S. Hershey Medical Center