Clinical trial NCT03996304: Health and Early Life Microbiota
Official title: Finnish Health and Early Life Microbiota (HELMi) Longitudinal Birth Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Development
Growth
Allergy
Overweight
Infectious Disease
Noncommunicable Diseases
Keywords: Birth cohort
Intestinal microbiota
Child health
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Business Finland
name: Valio Ltd
name: Finnish Red Cross Blood Service
name: DuPont Nutrition and Health
name: Oriola Corporation
name: Pikkujätti Medical Centre for Children and Youth
First posted: 2019-06-24
Enrollment: 1055
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort consists of 1055 healthy term infants born in 2016-2018 mainly at the capital region of Finland, and their parents.

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.

Eligibility 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

Primary outcomes:
measure: Longitudinal change of intestinal microbiota in early life
timeFrame: From 3 weeks to 2 years after birth
Secondary outcomes:
measure: Number of children with asthma
timeFrame: At 2 years
measure: Number of children with allergic disease
timeFrame: At 2 years
measure: Number of respiratory tract infection episodes
timeFrame: From birth to 2 years of age
measure: Weight
timeFrame: At 6,12,18 and 24 months after birth
measure: Growth
timeFrame: At 6,12,18 and 24 months after birth
measure: Child development
timeFrame: At 18 and 24 months after birth
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Human Microbiome Research Program, Faculty of Medicine, University of Helsinki
Study officials:
affiliation: University of Helsinki
name: Willem M de Vos, Professor
role: STUDY_DIRECTOR
affiliation: University of Helsinki
name: Anne Salonen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Helsinki
name: Kaija-Leena Kolho, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Korpela K, Kallio S, Salonen A, Hero M, Kukkonen AK, Miettinen PJ, Savilahti E, Kohva E, Kariola L, Suutela M, Tarkkanen A, de Vos WM, Raivio T, Kuitunen M. Gut microbiota develop towards an adult profile in a sex-specific manner during puberty. Sci Rep. 2021 Dec 2;11(1):23297. doi: 10.1038/s41598-021-02375-z.
citation: Korpela K, Dikareva E, Hanski E, Kolho KL, de Vos WM, Salonen A. Cohort profile: Finnish Health and Early Life Microbiota (HELMi) longitudinal birth cohort. BMJ Open. 2019 Jun 27;9(6):e028500. doi: 10.1136/bmjopen-2018-028500.