respiratory tract infections
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum
Eligibility
Age
No minimum to 11 Years
Inclusion criteria
Inclusion criteria: - Written informed consent obtained from both parents. - Child aged 1 up to and including 5 (1-5) years of age attending day care, peuterspeelzaal or school at least 2 (half) days a week. - Parents ability and willingness to adhere to protocol-specified procedures, including availability of a freezer at home to store samples.This does not include donation of saliva by parents themselves, which is related to a secondary endpoint.
Exclusion criteria
Exclusion criteria: - History of respiratory tract infections requiring hospitalization - Current use of antibiotics, or antibiotics use in past four weeks - Use of immune-altering medication (such as steroids, including inhaled corticosteroid) - No history of severe concomitant disease (severe congenital heart disease, bronchopulmonary dysplasia, prematurity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of systemic polysaccharide specific B cells in children that become colonised during the study versus children that do not become colonised | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pneumococcal colonisation presence and density over time. - Dynamics of other respiratory bacteria (such as Haemophilus influenzae and Staphylococcus aureus) and viruses (such as coronaviruses and influenza virus) during URT infection/colonisation, measured by molecular methods. - Local microbiota and microbial products - Nasal and systemic immune parameters, including antibodies, cytokines and metabolites. - Symptom questionnaires - Evaluation/sample tolerability questionnaire - Presence and load of bacteria and viruses in saliva of a subset of parents on a daily interval | — |
Countries
Netherlands
Outcome results
None listed