Gut Microbiota and Sleep in Infants Clinical Trial
— SDEGUOfficial title:
Sleep Behaviour and Gut Microbiota in Healthy Infants
| NCT number | NCT02836119 |
| Other study ID # | 2016-00730 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2016 |
| Est. completion date | December 2020 |
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.
| Status | Recruiting |
| Enrollment | 128 |
| Est. completion date | December 2020 |
| Est. primary completion date | December 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 2 Months to 13 Months |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | University Hospital Zurich | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich | University Children's Hospital, Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers) | across the first twelve months of life | ||
| Primary | Differences in Gut Microbiome Diversity (alpha, beta, Shannon) and taxa abundance and association with sleep phenotypes | across the first twelve months of life | ||
| Secondary | Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep) | across the first twelve months of life |