Health and Early Life Microbiota

NCT ID: NCT03996304

Last Updated: 2019-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1055 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-26

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Child Development Growth Allergy Overweight Infectious Disease Noncommunicable Diseases

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Business Finland

OTHER

Sponsor Role collaborator

Valio Ltd

INDUSTRY

Sponsor Role collaborator

Finnish Red Cross Blood Service

OTHER

Sponsor Role collaborator

DuPont Nutrition and Health

INDUSTRY

Sponsor Role collaborator

Oriola Corporation

UNKNOWN

Sponsor Role collaborator

Pikkujätti Medical Centre for Children and Youth

UNKNOWN

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Anne Salonen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Willem M de Vos, Professor

Role: STUDY_DIRECTOR

University of Helsinki

Anne Salonen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Kaija-Leena Kolho, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Locations

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

Helsinki, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 34857814 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31253623 (View on PubMed)

Other Identifiers

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263/13/03/03/2015

Identifier Type: -

Identifier Source: org_study_id

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