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Infant Sleep Behaviour and Gut Microbacteria (SDEGU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02836119
Recruitment Status : Recruiting
First Posted : July 18, 2016
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
University Children's Hospital, Zurich
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease
Gut Microbiota and Sleep in Infants

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Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Behaviour and Gut Microbiota in Healthy Infants
Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers) [ Time Frame: across the first twelve months of life ]
  2. 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 ]

Secondary Outcome Measures :
  1. Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep) [ Time Frame: across the first twelve months of life ]

Biospecimen Description:
Stool samples


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy infants
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836119


Contacts
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Contact: Sarah F. Schoch, M.Sc. 044 255 93 68 babysleep@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zurich, Switzerland, 8091
Contact: Sarah Schoch, M.Sc.    044 255 93 68 ext 0041    sarah.schoch@usz.ch   
Sponsors and Collaborators
University of Zurich
University Children's Hospital, Zurich
Investigators
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Principal Investigator: Salome Kurth, Dr. sc. nat. Clinic for Pulmonology
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02836119    
Other Study ID Numbers: 2016-00730
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Zurich:
Gut Microbiota
Gut Microbiome
Sleep
Infancy
Development