Infant Sleep Behaviour and Gut Microbacteria

NCT ID: NCT02836119

Last Updated: 2018-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Gut Microbiota and Sleep in Infants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

2 Months

Maximum Eligible Age

13 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salome Kurth, Dr. sc. nat.

Role: PRINCIPAL_INVESTIGATOR

Clinic for Pulmonology

Locations

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University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Sarah F. Schoch, M.Sc.

Role: CONTACT

044 255 93 68

Facility Contacts

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Sarah Schoch, M.Sc.

Role: primary

044 255 93 68 ext. 0041

Other Identifiers

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2016-00730

Identifier Type: -

Identifier Source: org_study_id

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