This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
Atlantia Food Clinical Trials
Cork, Ireland
Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI)
Presence of an URTI defined by a score of \>2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline
Time frame: Entire follow up period (total of 180 days)
Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI
The presence of an URTI defined by a score of \>2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants
Duration of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants
Severity of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the total number of reported missed days of school/childcare due to illness
Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use
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Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL)
Measured via saliva sample
Time frame: Day 0, Day 180
Effect of 26 week consumption of probiotic on the incidence of gastrointestinal infections
Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Time frame: Day 0, Day 90, Day 180