Child DevelopmentHELMiNCT03996304
Health and Early Life Microbiota
An observational study of Child Development and Growth, run by University of Helsinki at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Child Development, Growth, Allergy
- How many people
- 1,055 participants
- Where
- 1 siteFinland
- Study dates
- 26 Feb 2016to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The cohort consists of 1055 healthy term infants born in 2016-2018 mainly at the capital region of Finland, and their parents.
Who may be able to join
- 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
Who cannot join
- Preterm birth
- Severe birth defect
- Parents fail to activate the online questionnaires
Trial locations and contacts
1 site in 1 country.
Finland1 site
Human Microbiome Research Program, Faculty of Medicine, University of Helsinki
Helsinki
About this study
Official title: 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.
Read the 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.
- Conditions
- Child Development, Growth, Allergy, Overweight, Infectious Disease, Noncommunicable Diseases
- Keywords
- Birth cohort, Intestinal microbiota, Child health
- Medical subject headings
- Hypersensitivity, Overweight, Communicable Diseases, Noncommunicable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 3 weeks to 2 years after birth
Secondary outcomes (6)
Number of children with asthma
Specialist/Physician-diagnosed asthma.
Measured: At 2 years
Number of children with allergic disease
Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.
Measured: At 2 years
Number of respiratory tract infection episodes
Number of physician-diagnosed respiratory track infections.
Measured: From birth to 2 years of age
Weight
Weight in kilograms.
Measured: At 6,12,18 and 24 months after birth
Growth
Height in centimeters.
Measured: At 6,12,18 and 24 months after birth
Child development
By means of questionnaires and, on a randomly selected group of study subjects, developmental testing to assess cognitive, motor, socio-emotional and verbal development.
Measured: At 18 and 24 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start26 Feb 2016
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 1,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Business Finland, Valio Ltd, Finnish Red Cross Blood Service, DuPont Nutrition and Health, Oriola Corporation, Pikkujätti Medical Centre for Children and Youth
- Responsible party
- Principal investigator, Anne Salonen, University of Helsinki
- Investigators
- Willem M de Vos, Professor, Study director, University of HelsinkiAnne Salonen, PhD, Principal investigator, University of HelsinkiKaija-Leena Kolho, Professor, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996304
- Sponsor's protocol ID
- 263/13/03/03/2015
- Acronym
- HELMi
- Status last verified
- Jun 2019
- First submitted
- 26 Mar 2019
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34857814Korpela 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.
PubMed 31253623
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finnish Health and Early Life Microbiota (HELMi) Longitudinal Birth Cohort
- ClinicalTrials.gov ID
- NCT03996304
- Acronym / sponsor ID
- HELMi / 263/13/03/03/2015
- Conditions
- Child Development, Growth, Allergy, Overweight, Infectious Disease, Noncommunicable Diseases
- Keywords
- Birth cohort, Intestinal microbiota, Child health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,055 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Business Finland, Valio Ltd, Finnish Red Cross Blood Service, DuPont Nutrition and Health, Oriola Corporation, Pikkujätti Medical Centre for Children and Youth
- Study start
- 26 Feb 2016 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The cohort consists of 1055 healthy term infants born in 2016-2018 mainly at the capital region of Finland, and their parents.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Preterm birth
- Severe birth defect
- Parents fail to activate the online questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Number of children with asthma
Time frame: At 2 years
Number of children with allergic disease
Time frame: At 2 years
Number of respiratory tract infection episodes
Time frame: From birth to 2 years of age
Weight
Time frame: At 6,12,18 and 24 months after birth
Growth
Time frame: At 6,12,18 and 24 months after birth
Child development
Time frame: At 18 and 24 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
- Derived from this study: PubMed 34857814Korpela 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.
- Derived from this study: PubMed 31253623Korpela 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Willem M de Vos, Professor study director
University of Helsinki
Anne Salonen, PhD principal investigator
University of Helsinki
Kaija-Leena Kolho, Professor principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development and Growth, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal change of intestinal microbiota in early life (time frame: From 3 weeks to 2 years after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03996304, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019; AzTrials last refreshed its copy on 2 Nov 2026.