Health and Early Life Microbiota

• Conditions: Allergy; Noncommunicable Diseases; Child Development; Growth; Overweight; Infectious Disease

• Registration Number: NCT03996304
• Lead Sponsor: University of Helsinki

Brief Summary

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

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 Timeline

• Study Start: 2016-02-26
• Study First Submitted: 2019-03-26
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-21
• Last Update Submitted: 2019-06-21
• Study First Posted: 2019-06-24
• Last Update Posted: 2019-06-24
• Primary Completion: 2020-03-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1055

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Longitudinal change of intestinal microbiota in early life	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

Name	Time	Method
Weight	At 6,12,18 and 24 months after birth	Weight in kilograms.
Number of children with asthma	At 2 years	Specialist/Physician-diagnosed asthma.
Number of children with allergic disease	At 2 years	Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.
Child development	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.
Number of respiratory tract infection episodes	From birth to 2 years of age	Number of physician-diagnosed respiratory track infections.
Growth	At 6,12,18 and 24 months after birth	Height in centimeters.

Trial Locations

Locations (1)

Human Microbiome Research Program, Faculty of Medicine, University of Helsinki; 🇫🇮 Helsinki, Finland