Health and Early Life Microbiota

Overweight Clinical Trial

— HELMi  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03996304
• Other study ID #: 263/13/03/03/2015
• Status: Active, not recruiting
• Start date: February 26, 2016
• Est. completion date: August 31, 2020

Study information

• Verified date: June 2019
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 overweight.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1055
• Est. completion date: August 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Allergy
• Child Development
• Communicable Diseases
• Growth
• Infection
• Infectious Disease
• Noncommunicable Diseases
• Overweight

Locations

Country	Name	City	State
Finland	Human Microbiome Research Program, Faculty of Medicine, University of Helsinki	Helsinki

Sponsors (7)

Lead Sponsor	Collaborator
Helsinki University	Business Finland, DuPont Nutrition and Health, Finnish Red Cross, Oriola Corporation, Pikkujätti Medical Centre for Children and Youth, Valio Ltd

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From 3 weeks to 2 years after birth
Secondary	Number of children with asthma	Specialist/Physician-diagnosed asthma.	At 2 years
Secondary	Number of children with allergic disease	Specialist/Physician-diagnosed wheeze, eczema/atopic dermatitis, allergic rhinitis, food allergy or atopy.	At 2 years
Secondary	Number of respiratory tract infection episodes	Number of physician-diagnosed respiratory track infections.	From birth to 2 years of age
Secondary	Weight	Weight in kilograms.	At 6,12,18 and 24 months after birth
Secondary	Growth	Height in centimeters.	At 6,12,18 and 24 months after birth
Secondary	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.	At 18 and 24 months after birth