Health and Early Life Microbiota

University of Helsinki1,055 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,055

Conditions

Child Development Growth Allergy Overweight Infectious Disease Noncommunicable Diseases

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Human Microbiome Research Program, Faculty of Medicine, University of Helsinki

Helsinki, Finland

Outcomes

Primary Outcomes

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.

Time frame: From 3 weeks to 2 years after birth

Secondary Outcomes

Number of children with asthma

Specialist/Physician-diagnosed asthma.

Time frame: At 2 years

Number of children with allergic disease

Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.

Time frame: At 2 years

Number of respiratory tract infection episodes

Number of physician-diagnosed respiratory track infections.

Time frame: From birth to 2 years of age

Weight

Weight in kilograms.

Time frame: At 6,12,18 and 24 months after birth

Growth

Height in centimeters.

Time frame: 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.

Time frame: At 18 and 24 months after birth

Data from ClinicalTrials.gov

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