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Health and Early Life Microbiota (HELMi)

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ClinicalTrials.gov Identifier: NCT03996304
Recruitment Status : Active, not recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Collaborators:
Business Finland
Valio Ltd
Finnish Red Cross
DuPont Nutrition and Health
Oriola Corporation
Pikkujätti Medical Centre for Children and Youth
Information provided by (Responsible Party):
Anne Salonen, Helsinki University

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.

Condition or disease
Child Development Growth Allergy Overweight Infectious Disease Noncommunicable Diseases

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.

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Study Type : Observational
Actual Enrollment : 1055 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Finnish Health and Early Life Microbiota (HELMi) Longitudinal Birth Cohort
Actual Study Start Date : February 26, 2016
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : August 31, 2020



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of children with asthma [ Time Frame: At 2 years ]
    Specialist/Physician-diagnosed asthma.

  2. Number of children with allergic disease [ Time Frame: At 2 years ]
    Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.

  3. Number of respiratory tract infection episodes [ Time Frame: From birth to 2 years of age ]
    Number of physician-diagnosed respiratory track infections.

  4. Weight [ Time Frame: At 6,12,18 and 24 months after birth ]
    Weight in kilograms.

  5. Growth [ Time Frame: At 6,12,18 and 24 months after birth ]
    Height in centimeters.

  6. 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.


Biospecimen Retention:   Samples With DNA
  • Faecal samples from study infants
  • Faecal samples from parents
  • Buccal swap DNA sample from study infants
  • Breast milk


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03996304


Locations
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Finland
Human Microbiome Research Program, Faculty of Medicine, University of Helsinki
Helsinki, Finland
Sponsors and Collaborators
Helsinki University
Business Finland
Valio Ltd
Finnish Red Cross
DuPont Nutrition and Health
Oriola Corporation
Pikkujätti Medical Centre for Children and Youth
Investigators
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Study Director: Willem M de Vos, Professor Helsinki University
Principal Investigator: Anne Salonen, PhD Helsinki University
Principal Investigator: Kaija-Leena Kolho, Professor Helsinki University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anne Salonen, Principal Investigator, Helsinki University
ClinicalTrials.gov Identifier: NCT03996304     History of Changes
Other Study ID Numbers: 263/13/03/03/2015
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Salonen, Helsinki University:
Birth cohort
Intestinal microbiota
Child health
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Overweight
Noncommunicable Diseases
Body Weight
Signs and Symptoms
Chronic Disease
Disease Attributes
Pathologic Processes