Influences of external determinants on the physiological development and composition of the infant microbiome in healthy infants from birth during the first 6 years of life using novel molecular techniques. Subclinical and clinical disease, transmission, and risk factors of SARS-CoV-2 among children and their families: a household study within the "Microbiome Healthy Infant Study"

Influences of external determinants on the physiological development and composition of the infant microbiome in healthy infants from birth during the first 6 years of life using novel molecular techniques. Subclinical and clinical disease, transmission, and risk factors of SARS-CoV-2 among children and their families: a household study within the "Microbiome Healthy Infant Study" - Microbiome healthy Infant Study CoKids study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50226

Enrollment

130

Registered

2012-09-09

Start date

2012-11-20

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infecties, virale infectieziekten carriage microbial colonisation SARS-CoV-2 transmission

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Neonates born after 37 weeks of gestational age 2. Born in the region Groot Kennemerland and Bollenstreek (draining on Spaarne hospital in Hoofddorp or Kennemer Gasthuis in Haarlem). Inclusion criteria for COVID-19 related part: 1. Household member of participating children in the birth cohort study (including participating children themselves) 2. Written informed consent obtained from parents 3. Parents ability and willingness to adhere to protocol-specified procedures.

Exclusion criteria

Exclusion criteria: 1.Severe perinatal/ neonatal/ maternal complications as asphyxia, resuscitation, transfer to neonatal intensive care unit etc. 2.Major congenital anomalies. 3.Language barrier. 4.Intention to move outside the research area. 5.Parents under the age of 18 years. For CoKids study: None

Design outcomes

Primary

Measure	Time frame
1. Comparison of the composition of infant microbiome between infants born vaginally and infants born by caesarean section at several time points during the first 12 months of life. 2. The dynamics of the infant nasopharyngeal and oral microbiome with age and in periods of respiratory infections. 3. To study the human microbiome of children till age 6 in relation to health status, life style and environmental factors CoKids: 1. SARS-CoV-2 symptoms, infection, severity of disease and transmission	—

Measure

Time frame

1. Comparison of the composition of infant microbiome between infants born vaginally and infants born by caesarean section at several time points during the first 12 months of life. 2. The dynamics of the infant nasopharyngeal and oral microbiome with age and in periods of respiratory infections. 3. To study the human microbiome of children till age 6 in relation to health status, life style and environmental factors CoKids: 1. SARS-CoV-2 symptoms, infection, severity of disease and transmission

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Secondary

Measure	Time frame
The secondary study parameters/endpoints: 1. The relation between nasopharyngeal, oral, gastrointestinal and skin microbiome. 2. The dynamics of the microbiome in periods of antibiotic consumption. 3. Comparison of the composition of the maternal microbiome and the child microbiome. 4. Comparison of the composition of the child microbiome between breastfed infants and formula fed infants. 5. The dynamics of the child microbiome in case of eczema/atopic diseases. 6. The dynamics of the child microbiome related to exposure and environment (father, siblings, day care). 7. The composition of breast milk in relation to the infant microbiome 8. The relation of microbiome to immunoglobulin and antibody development in saliva 9. The respiratory microbiome in relation to respiratory health, including medication over last six years and lung function parameters. Exploratory end points 10. The dynamics of the early and childhood microbiome in relation to serum immunoglobulins, specific antibodies, immune IgE, T cell profile and Th1/Th2/Treg/Th17 status. 11. Nutrition (including supplements like pre- and probiotics and vitamins) in relation to the oral, gut and respiratory microbiome. 12. The microbiome in relation to gastrointestinal complaints and weight development, length and blood pressure. 13. The distance of the residential address to an international airport in relation to the respiratory microbiome 14. The relationship of oral hygiene behaviour and the oral microbiome 15. The relationship of the oral microbiome and caries. 16. The relationship between sleep behaviour and physical exercise and the development of the respiratory, oral, gut and skin microbiome.	—

Measure

Time frame

The secondary study parameters/endpoints: 1. The relation between nasopharyngeal, oral, gastrointestinal and skin microbiome. 2. The dynamics of the microbiome in periods of antibiotic consumption. 3. Comparison of the composition of the maternal microbiome and the child microbiome. 4. Comparison of the composition of the child microbiome between breastfed infants and formula fed infants. 5. The dynamics of the child microbiome in case of eczema/atopic diseases. 6. The dynamics of the child microbiome related to exposure and environment (father, siblings, day care). 7. The composition of breast milk in relation to the infant microbiome 8. The relation of microbiome to immunoglobulin and antibody development in saliva 9. The respiratory microbiome in relation to respiratory health, including medication over last six years and lung function parameters. Exploratory end points 10. The dynamics of the early and childhood microbiome in relation to serum immunoglobulins, specific antibodies, immune IgE, T cell profile and Th1/Th2/Treg/Th17 status. 11. Nutrition (including supplements like pre- and probiotics and vitamins) in relation to the oral, gut and respiratory microbiome. 12. The microbiome in relation to gastrointestinal complaints and weight development, length and blood pressure. 13. The distance of the residential address to an international airport in relation to the respiratory microbiome 14. The relationship of oral hygiene behaviour and the oral microbiome 15. The relationship of the oral microbiome and caries. 16. The relationship between sleep behaviour and physical exercise and the development of the respiratory, oral, gut and skin microbiome.

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Countries

Netherlands

Outcome results