Nutrition, Microbiome and Bone Health During Early Life Related to Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,760
- 试验地点
- 1
- 主要终点
- dietary factors
研究概览
简要总结
The aim of the study is to establish the longitudinal microbiome and bone trajectories from birth to 3 years, and to evaluate the influence of nutrition on these trajectories.
详细描述
The main objective of the study is to understand the influence of nutrition and dietary patterns on microbiome and bone trajectories during early life. Specific research objectives are:
- Establish the reference trajectories of gut microbiome maturation index and bone development in healthy Chinese children aged 0-3years
- Assess the impact of early life nutrition on gut microbiome trajectory
- Investigate the influence of microbiome, early life parameters and nutritional parameters on bone health
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
- 0 Days 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It is important to carefully consider whether a subject is suitable for enrollment into this observational study. Fulfillment of the inclusion and exclusion criteria for each subject will be documented by a qualified member of the investigative staff before any subject is enrolled.
- •Healthy infants who fulfill all the following inclusion criteria will be included:
- •Having obtained his/her parents' (or his/her legally accepted representative's [LAR's]) written informed consent and having evidence of personally signed and dated informed consent document indicating that the subject's parents/LAR have been informed of all pertinent aspects of the study.
- •Subject's parent(s)/LAR is of legal age of consent, is willing and able to fulfill the requirements of the study protocol.
- •For group 1, healthy infants aged ≤ 10 days after birth (date of birth = Day 0).
- •For group 2, healthy infants with maximum age of 6 months
- •Full-term gestational birth (≥ 37 and ≤ 42 weeks).
- •Subject's parent(s)/LAR is able to be contacted directly by telephone throughout the study.
- •Both parents registered have a fixed work and / or residence within their jurisdiction.
排除标准
- •Complicated pregnancy (e.g., preeclampsia, gestational diabetes, bowel disease) as assessed by medical interview/ medical record when available
- •Infant's parents/LAR not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
- •Currently participating or having participated in another clinical trial within 4 weeks prior to trial start.
结局指标
主要结局
dietary factors
时间窗: Group 1: 0-1 year, Group 2: 0.5-3 years
derived from food diaries of the types of complementary feeding, the food consumption, the nutrient intakes, the food source of nutrients, the dietary patterns
gut microbiome
时间窗: Group 1: 0-1 year, Group 2: 0.5-3 years
microbiome maturation index derived from microbial composition, bacteria function, metabolites
bone development
时间窗: Group 1: 0-1 year, Group 2: 0.5-3 years
bone tibia speed of sounds (SOS) (meter / second) using ultrasound
bone health
时间窗: Group 1: 0-1 year, Group 2: 0.5-3 years
Bone tibia length using ruler (cm)
dietary intakes and health outcomes
时间窗: Group 1: 0-1 year, Group 2: 0.5-3 years
derived from infant questionnaires and their food diaries of the types of complementary feeding, the food consumption, the nutrient intakes, the food source of nutrients, the dietary patterns
次要结局
- Urinary markers of bone metabolism(Group 1: 0-1 year, Group 2: 0.5-3 years)
- Gut microbiome(Group 1: 0-1 year, Group 2: 0.5-3 years)
- breast milk composition(Group 1: 0-3 months)