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Infant Sleep Behaviour and Gut Microbacteria (SDEGU)

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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

Tracking Information
First Submitted Date July 11, 2016
First Posted Date July 18, 2016
Last Update Posted Date June 12, 2018
Study Start Date July 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2016)
  • Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers) [ Time Frame: 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 13, 2016)
Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep) [ Time Frame: across the first twelve months of life ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Infant Sleep Behaviour and Gut Microbacteria
Official Title Sleep Behaviour and Gut Microbiota in Healthy Infants
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Stool samples
Sampling Method Probability Sample
Study Population Healthy infants
Condition Gut Microbiota and Sleep in Infants
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 13, 2016)
128
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Months to 13 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sarah F. Schoch, M.Sc. 044 255 93 68 babysleep@usz.ch
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02836119
Other Study ID Numbers 2016-00730
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators University Children's Hospital, Zurich
Investigators
Principal Investigator: Salome Kurth, Dr. sc. nat. Clinic for Pulmonology
PRS Account University of Zurich
Verification Date June 2018