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Infant Sleep Behaviour and Gut Microbacteria

Conditions
Gut Microbiota and Sleep in Infants
Registration Number
NCT02836119
Lead Sponsor
University of Zurich
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
128
Inclusion Criteria
  • Good general health status
  • exclusively breastfed (at baseline)
  • vaginal birth delivery mode
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Exclusion Criteria
  • 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)
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers)across the first twelve months of life
Differences in Gut Microbiome Diversity (alpha, beta, Shannon) and taxa abundance and association with sleep phenotypesacross the first twelve months of life
Secondary Outcome Measures
NameTimeMethod
Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep)across the first twelve months of life

Trial Locations

Locations (1)

University Hospital Zurich

🇨🇭

Zurich, Switzerland

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