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Health and Early Life Microbiota

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03996304
Acronym
HELMi
Enrollment
1055
Registered
2019-06-24
Start date
2016-02-26
Completion date
2020-08-31
Last updated
2019-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Birth cohort, Intestinal microbiota, Child health

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.

Interventions

None listed

Sponsors

Business Finland
CollaboratorOTHER
Valio Ltd
CollaboratorINDUSTRY
Finnish Red Cross Blood Service
CollaboratorOTHER
DuPont Nutrition and Health
CollaboratorINDUSTRY
Oriola Corporation
CollaboratorUNKNOWN
Pikkujätti Medical Centre for Children and Youth
CollaboratorUNKNOWN
University of Helsinki
Lead SponsorOTHER

Study design

Observational model
FAMILY_BASED
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

* Preterm birth * Severe birth defect * Parents fail to activate the online questionnaires

Design outcomes

Primary

MeasureTime frameDescription
Longitudinal change of intestinal microbiota in early lifeFrom 3 weeks to 2 years after birthDevelopmental 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

MeasureTime frameDescription
Number of children with allergic diseaseAt 2 yearsSpecialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.
Number of respiratory tract infection episodesFrom birth to 2 years of ageNumber of physician-diagnosed respiratory track infections.
Number of children with asthmaAt 2 yearsSpecialist/Physician-diagnosed asthma.
GrowthAt 6,12,18 and 24 months after birthHeight in centimeters.
Child developmentAt 18 and 24 months after birthBy means of questionnaires and, on a randomly selected group of study subjects, developmental testing to assess cognitive, motor, socio-emotional and verbal development.
WeightAt 6,12,18 and 24 months after birthWeight in kilograms.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026