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Health and Early Life Microbiota (HELMi)

U

University of Helsinki

Status

Unknown

Conditions

Noncommunicable Diseases
Overweight
Child Development
Infectious Disease
Allergy
Growth

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03996304
263/13/03/03/2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,055 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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