Infant Sleep Behaviour and Gut Microbacteria (SDEGU)

June 11, 2018 updated by: University of Zurich

Sleep Behaviour and Gut Microbiota in Healthy Infants

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital Zurich
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy infants

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers)
Time Frame: across the first twelve months of life
across the first twelve months of life
Differences in Gut Microbiome Diversity (alpha, beta, Shannon) and taxa abundance and association with sleep phenotypes
Time Frame: across the first twelve months of life
across the first twelve months of life

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

University Children's Hospital, Zurich

Investigators

  • Principal Investigator: Salome Kurth, Dr. sc. nat., Clinic for Pulmonology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 11, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

June 12, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016-00730

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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