NCT02836119Unknown不适用
Sleep Behaviour and Gut Microbiota in Healthy Infants
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers)
研究概览
简要总结
The overarching study aim is to evaluate the development of sleep behavior and gut microbiota (GMB), and their potential interaction, during the vulnerable period of the first year of life. Age-specific fecal profiles with bacterial genome sequencing will provide new insight into the functional coevolution of the GMB and host sleep behavior.
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
- 2 Months 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health status
- •exclusively breastfed (at baseline)
- •vaginal birth delivery mode
排除标准
- •C-section delivery mode
- •Formula fed (at baseline)
- •Diseases or lesions of the central nervous system, acute pediatric disease, developmental/neurologic/metabolic disorders, chronic medical conditions, or head injury
- •Family history of narcolepsy/psychosis/bipolar disorder
- •Conceptual age of < 37 or > 42 weeks
- •Low birth weight (< 2500g)
- •Co-sleeping during > 50% of the time in the same bed
- •Medication use affecting sleep/alertness
- •Vaccination (2 weeks prior to study)
- •Antibiotics (3 months prior to study)
- •Travelling across a time zone (within 1 month prior to study)
- •intrauterine drug exposure, intrauterine infection, known or suspected drug or alcohol abuse
- •Insufficient knowledge of German (parents)
结局指标
主要结局
Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers)
时间窗: across the first twelve months of life
Differences in Gut Microbiome Diversity (alpha, beta, Shannon) and taxa abundance and association with sleep phenotypes
时间窗: across the first twelve months of life
次要结局
- Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep)(across the first twelve months of life)
研究者
研究点 (1)
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