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ClinicalTrials.gov Identifier: NCT03996304
Recruitment Status : Unknown
Verified June 2019 by Anne Salonen, University of Helsinki. Recruitment status was: Active, not recruiting
The aim of this cohort is to identify environmental, lifestyle and genetic factors that modify the human intestinal microbiota development during the first years of life, and to identify early microbiota features that associate to child health and well-being with focus on the development of allergic diseases and overweight.
1055 healthy term infants born in 2016-2018 mainly at the capital region of Finland, and their parents. Fecal samples collected from infants and their parents. Electronic questionnaires on a weekly basis during the first 4 months of life, thereafter less frequently. Focus on diet, well-being and health and social manners. At one-year and at two-years comprehensive questionnaires including development and cognition. Parental stress evaluation included.
Longitudinal change of intestinal microbiota in early life [ Time Frame: From 3 weeks to 2 years after birth ]
Developmental trajectory of the intestinal microbiota, assessed with 16S rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from week 3 to weeks 6,9,12 and months 6,9,12,18 and 24 after birth.
Secondary Outcome Measures :
Number of children with asthma [ Time Frame: At 2 years ]
Number of children with allergic disease [ Time Frame: At 2 years ]
Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.
Number of respiratory tract infection episodes [ Time Frame: From birth to 2 years of age ]
Number of physician-diagnosed respiratory track infections.
Weight [ Time Frame: At 6,12,18 and 24 months after birth ]
Weight in kilograms.
Growth [ Time Frame: At 6,12,18 and 24 months after birth ]
Height in centimeters.
Child development [ Time Frame: At 18 and 24 months after birth ]
By means of questionnaires and, on a randomly selected group of study subjects, developmental testing to assess cognitive, motor, socio-emotional and verbal development.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The cohort consists of 1055 healthy term infants born in 2016-2018 mainly at the capital region of Finland, and their parents.
General population, singleton pregnancy, at least one parent Finnish speaking
Willingness and ability of parents to consent for 2 year follow-up involving frequent electronic questionnaires and freezing of faecal samples at home
Infant born on gestational weeks 37-42 without known congenital defects
Severe birth defect
Parents fail to activate the online questionnaires