Infant Sleep Behaviour and Gut Microbacteria (SDEGU)
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ClinicalTrials.gov Identifier: NCT02836119
Recruitment Status : Unknown
Verified June 2018 by University of Zurich. Recruitment status was: Recruiting
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.
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Layout table for eligibility information
Ages Eligible for Study:
2 Months to 13 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Good general health status
exclusively breastfed (at baseline)
vaginal birth delivery mode
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