Health and Early Life Microbiota (HELMi)

June 21, 2019 updated by: Anne Salonen, University of Helsinki

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1055

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Family-Based
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal change of intestinal microbiota in early life
Time Frame: From 3 weeks to 2 years after birth
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of children with asthma
Time Frame: At 2 years
Specialist/Physician-diagnosed asthma.
At 2 years
Number of children with allergic disease
Time Frame: At 2 years
Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.
At 2 years
Number of respiratory tract infection episodes
Time Frame: From birth to 2 years of age
Number of physician-diagnosed respiratory track infections.
From birth to 2 years of age
Weight
Time Frame: At 6,12,18 and 24 months after birth
Weight in kilograms.
At 6,12,18 and 24 months after birth
Growth
Time Frame: At 6,12,18 and 24 months after birth
Height in centimeters.
At 6,12,18 and 24 months after birth
Child development
Time Frame: At 18 and 24 months after birth
By means of questionnaires and, on a randomly selected group of study subjects, developmental testing to assess cognitive, motor, socio-emotional and verbal development.
At 18 and 24 months after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Business Finland
Finnish Red Cross
Valio Ltd
DuPont Nutrition and Health
Oriola Corporation
Pikkujätti Medical Centre for Children and Youth

Investigators

  • Study Director: Willem M de Vos, Professor, University of Helsinki
  • Principal Investigator: Anne Salonen, PhD, University of Helsinki
  • Principal Investigator: Kaija-Leena Kolho, Professor, University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2016

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

August 31, 2020

Study Registration Dates

First Submitted

March 26, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 24, 2019

Study Record Updates

Last Update Posted (Actual)

June 24, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 263/13/03/03/2015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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