Health and Early Life Microbiota (HELMi)
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ClinicalTrials.gov Identifier: NCT03996304 |
Recruitment Status : Unknown
Verified June 2019 by Anne Salonen, University of Helsinki.
Recruitment status was: Active, not recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
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Condition or disease |
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Child Development Growth Allergy Overweight Infectious Disease Noncommunicable Diseases |
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 |
- 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.
- Number of children with asthma [ Time Frame: At 2 years ]Specialist/Physician-diagnosed asthma.
- Number of children with allergic disease [ Time Frame: At 2 years ]Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.
- Number of respiratory tract infection episodes [ Time Frame: From birth to 2 years of age ]Number of physician-diagnosed respiratory track infections.
- Weight [ Time Frame: At 6,12,18 and 24 months after birth ]Weight in kilograms.
- Growth [ Time Frame: At 6,12,18 and 24 months after birth ]Height in centimeters.
- 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 |
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
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
Finland | |
Human Microbiome Research Program, Faculty of Medicine, University of Helsinki | |
Helsinki, Finland |
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 |
Responsible Party: | Anne Salonen, Principal Investigator, University of Helsinki |
ClinicalTrials.gov Identifier: | NCT03996304 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Birth cohort Intestinal microbiota Child health |
Communicable Diseases Infections Overweight Noncommunicable Diseases Overnutrition |
Nutrition Disorders Body Weight Disease Attributes Pathologic Processes |