NCT03996304

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,055

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2016

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

4.1 years

First QC Date

March 26, 2019

Last Update Submit

June 21, 2019

Conditions

Child DevelopmentGrowthAllergyOverweightInfectious DiseaseNoncommunicable Diseases

Keywords

Birth cohortIntestinal microbiotaChild health

Outcome Measures

Primary Outcomes (1)

  • Longitudinal change of intestinal microbiota in early life

    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.

    From 3 weeks to 2 years after birth

Secondary Outcomes (6)

  • Number of children with asthma

    At 2 years

  • Number of children with allergic disease

    At 2 years

  • Number of respiratory tract infection episodes

    From birth to 2 years of age

  • Weight

    At 6,12,18 and 24 months after birth

  • Growth

    At 6,12,18 and 24 months after birth

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Microbiome Research Program, Faculty of Medicine, University of Helsinki

Helsinki, Finland

Location

Related Publications (2)

  • 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.

    PMID: 34857814DERIVED

  • 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.

    PMID: 31253623DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

* Faecal samples from study infants * Faecal samples from parents * Buccal swap DNA sample from study infants * Breast milk

MeSH Terms

Conditions

HypersensitivityOverweightCommunicable DiseasesNoncommunicable Diseases

Condition Hierarchy (Ancestors)

Immune System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsDisease AttributesPathologic Processes

Study Officials

  • Willem M de Vos, Professor

    University of Helsinki

    STUDY DIRECTOR

  • Anne Salonen, PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

  • Kaija-Leena Kolho, Professor

    University of Helsinki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2019

First Posted

June 24, 2019

Study Start

February 26, 2016

Primary Completion

March 31, 2020

Study Completion

August 31, 2020

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations

FI(1)