Health and Early Life Microbiota

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Finnish Health and Early Life Microbiota (HELMi) Longitudinal Birth Cohort

Conditions
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Child Development, Growth, Allergy, Overweight, Infectious Disease, Noncommunicable Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria Preterm birth Severe birth defect Parents fail to activate the online questionnaires
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal change of intestinal microbiota in early life | 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. | From 3 weeks to 2 years after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of children with asthma | Specialist/Physician-diagnosed asthma. | At 2 years | 
| Number of children with allergic disease | Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy. | At 2 years | 
| Number of respiratory tract infection episodes | Number of physician-diagnosed respiratory track infections. | From birth to 2 years of age | 
| Weight | Weight in kilograms. | At 6,12,18 and 24 months after birth | 
| Growth | Height in centimeters. | At 6,12,18 and 24 months after birth | 
| Child development | By means of questionnaires and, on a randomly selected group of study subjects, developmental testing to assess cognitive, motor, socio-emotional and verbal development. | At 18 and 24 months after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Birth cohort, Intestinal microbiota, Child health