This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
619
Lactobacillus
Placebo
CPS Research
Glasgow, United Kingdom
The incidence of URTI
The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, adjusted for sample size.
Time frame: 16 weeks
The incidence of URTI with pathogens
The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, for which a pathogen is identified in nasal swabs, adjusted for sample size.
Time frame: 16 weeks
The Number of days with URTI symptoms
The number of days with URTI symptoms for URTIs that were diagnosed by a GP, adjusted for sample size.
Time frame: 16 weeks
The number of days with temperature ≥ 38 °C
The number of days with temperature ≥ 38 °C during an URTI episode, which was diagnosed by a GP, adjusted for sample size.
Time frame: 16 weeks
WURSS-K score
The Area under Curve for daily Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) score (range: not sick - very sick) during an URTI episode, which was diagnosed by a GP, adjusted for sample size.
Time frame: 16 weeks
The number of subjects with one or more episode of URTI
The number of subjects with one or more episode of URTI, which was diagnosed by a GP, adjusted for sample size.
Time frame: 16 weeks
The number of days of absence from daycare or primary school
The number of days of absence from daycare or primary school during an URTI, which was diagnosed by a GP, adjusted for sample size.
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Time frame: 16 weeks