Infant Sleep Behaviour and Gut Microbacteria (SDEGU)

University of Zurich (UZH)

Status: Unknown

Conditions: Gut Microbiota and Sleep in Infants

Study type: Observational

Funder types: Other

Identifiers

NCT02836119

2016-00730

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 2 to 13 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Good general health status
• exclusively breastfed (at baseline)
• vaginal birth delivery mode

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)