Infant Sleep Behaviour and Gut Microbacteria

Sleep Behaviour and Gut Microbiota in Healthy Infants

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02836119

Acronym

SDEGU

Enrollment

128

Registered

2016-07-18

Start date

2016-07-31

Completion date

2020-12-31

Last updated

2018-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gut Microbiota and Sleep in Infants

Keywords

Gut Microbiota, Gut Microbiome, Sleep, Infancy, Development

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Months to 13 Months

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
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 phenotypes	across the first twelve months of life

Secondary

Measure	Time frame
Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep)	across the first twelve months of life

Countries

Switzerland

Contacts

Primary ContactSarah F. Schoch, M.Sc.

babysleep@usz.ch044 255 93 68

Outcome results