HELMi: Health and Early Life Microbiota

Sponsor

University of Helsinki (Other)

Overall Status

Unknown status

CT.gov ID

NCT03996304

Collaborator

Business Finland (Other), Valio Ltd (Industry), Finnish Red Cross (Other), DuPont Nutrition and Health (Industry), Oriola Corporation (Other), Pikkujätti Medical Centre for Children and Youth (Other)

1,055

Enrollment

Location

54.1

Anticipated Duration (Months)

19.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child Development Growth Allergy Overweight Infectious Disease Noncommunicable Diseases

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 Design

Study Type:

Observational

Actual Enrollment :

1055 participants

Observational Model:

Family-Based

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 26, 2016

Anticipated Primary Completion Date :

Mar 31, 2020

Anticipated Study Completion Date :

Aug 31, 2020

Outcome Measures

Primary Outcome Measures

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

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.
Number of respiratory tract infection episodes [From birth to 2 years of age]
Number of physician-diagnosed respiratory track infections.
Weight [At 6,12,18 and 24 months after birth]
Weight in kilograms.
Growth [At 6,12,18 and 24 months after birth]
Height in centimeters.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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