Gut Microbiota and Sleep in InfantsSDEGUNCT02836119
Infant Sleep Behaviour and Gut Microbacteria
An observational study of Gut Microbiota and Sleep in Infants, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota and Sleep in Infants
- How many people
- 128 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy infants
Who may be able to join
- Good general health status
- exclusively breastfed (at baseline)
- vaginal birth delivery mode
Who cannot join
- 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)
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Sarah Schoch, M.Sc., 044 255 93 68 ext. 0041, sarah.schoch@usz.ch
About this study
Official title: 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.
- Conditions
- Gut Microbiota and Sleep in Infants
- Keywords
- Gut Microbiota, Gut Microbiome, Sleep, Infancy, Development
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers)
Measured: across the first twelve months of life
Differences in Gut Microbiome Diversity (alpha, beta, Shannon) and taxa abundance and association with sleep phenotypes
Measured: across the first twelve months of life
Secondary outcomes (1)
Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep)
Measured: across the first twelve months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut Microbiota and Sleep in InfantsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Children's Hospital, Zurich
- Responsible party
- Sponsor
- Investigators
- Salome Kurth, Dr. sc. nat., Principal investigator, Clinic for Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836119
- Sponsor's protocol ID
- 2016-00730
- Other IDs
- 2016
- Acronym
- SDEGU
- Status last verified
- Jun 2018
- First submitted
- 11 Jul 2016
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Behaviour and Gut Microbiota in Healthy Infants
- ClinicalTrials.gov ID
- NCT02836119
- Acronym / sponsor ID
- SDEGU / 2016-00730
- Conditions
- Gut Microbiota and Sleep in Infants
- Keywords
- Gut Microbiota, Gut Microbiome, Sleep, Infancy, Development
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Children's Hospital, Zurich
- Study start
- Jul 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy infants
Key inclusion criteria (3 listed)
- Good general health status
- exclusively breastfed (at baseline)
- vaginal birth delivery mode
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Association of primary outcome measures with cognitive and behavioral questionnaires (Food, development, Sleep)
Time frame: across the first twelve months of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Gut Microbiota and Sleep in Infants
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Chrononutrition in Preterm Infants: a Randomised Controlled Trial of Time-matched Breast Milk Feeding and Its Effects on Sleep and Circadian Development
Infant Sleep Problems, Circadian Rhythm
RecruitingObservational study
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Malnutrition Pregnancy, Malnutrition in Children
Not yet recruiting
NapBiome: Targeting Gut Microbiota and Sleep Rhythm to Improve Developmental and Behavioral Outcomes in Early Childhood
Sleep Problem, Neurobehavioral Manifestations
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salome Kurth, Dr. sc. nat. principal investigator
Clinic for Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiota and Sleep in Infants, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah F. Schoch, M.Sc. (044 255 93 68, babysleep@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in sleep phenotypes (high fragmentation vs low fragmentation, short vs long sleepers) (time frame: across the first twelve months of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.