- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03296631
Phages Dynamics and Influences During Human Gut Microbiome Establishment (METAKIDS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Essonne
-
Orsay, Essonne, France, 91400
- Crèche du Parc
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Orsay, Essonne, France, 91400
- Crèche La Farandole
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Child attending at least 4 days a week one of the two municipal municipal nursery (crèches) in the town of Orsay (91, France);
- Aged less than 9 months at the time of entry to the crèche (August-October 2017);
- Parent (s) / legal representative not opposed to the child's participation in the research;
Exclusion Criteria:
- Toilet training;
- Prematurity;
- Participation in clinical research requiring the use of a drug.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
children
Enrollment of 15 to 20 children (< 9 months old) at the early beginning of their entry in nursery (crèche) between August and November 2017. This cohort will be followed during a maximum period of 36 months . Diapers with fresh stools will be collected once a week per child and then frozen. Spontaneous personal day care informations given by the parents to the nurses and recorded in each child's daily logbook will be collected for the research. No specific interviews will be conducted. |
collection of diapers with fresh stools
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterization of phages and bacteria genomes during infant gut development.
Time Frame: 3 years
|
Genomic reconstruction and characterization of the different genomes (phages, bacteria, yeast) present in the human gut during the three first years of life.
This outcomes will provide a large catalog of DNA sequences.
|
3 years
|
Characterization of phages and bacteria abundance and variations during infant gut development
Time Frame: 3 years
|
Characterization of the variation of the different species present in human gut during the 3 first years of life.
This outcomes will provide access to the dynamics of the different species present during this period and possibility to correlate them with environmental variation (dietary, age)
|
3 years
|
Characterization of phages-bacteria interactions
Time Frame: 3 years
|
Phages are the major predator of bacteria but their role during human gut establishment remains poorly characterized.
This catalog of interactions will allow to understand the role of the phages during human gut development
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterization of phages and bacteria variations in response to environmental perturbations during infant gut development
Time Frame: 2 to 3 weeks
|
Characterization of the small variations of the different species present in human gut during the 3 first years of life in response to environmental perturbations.
This outcome will provide access to the dynamics of the different species present during this period and possibility to correlate them with environmental perturbations (antibiotic, vaccine, illness).
|
2 to 3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Martial Marbouty, Institut Pasteur / CNRS
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016-097
- ID RCB number : 2017-A00750-53 (OTHER: French national registration number of the study)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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