This study investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children.
Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) have been shown to significantly reduce the number of febrile days and pain severity in upper respiratory tract infections in children aged six months to 5 years. The investigator's planned study complements this earlier publication by significantly increasing the number of cases and expanding the age range studied including children from 4 to 17 years of age diagnosed with viral upper respiratory-tract infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
142
BioGaia Pharax drops (with PTA5289 and DSM 17938) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension.
Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.
Szent Miklós Szolgálat Kft.
Szigetszentmiklós, Pest County, Hungary
RECRUITINGTime to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs)
Time frame: 10 days
Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired)
Time frame: 10 days
Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) recorded in a "Symptom Diary".
On a scale from 1 to 8.
Time frame: 10 days
Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day.
Time frame: 10 days
Amount of NSAIDs used.
Time frame: 10 days
Number of children receiving antibiotic treatment in each treatment group.
Time frame: 10 days
Total amount of days of antibiotic use during the study, reported during the whole duration of the study in a the "Symptom Diary".
Time frame: 10 days
Number of unplanned medical visits (other than "Visit 1 and 2").
This outcome is defined as the total amount of medical office visits or emergency visits.
Time frame: 10 days
Days of absences from day care center/school.
This outcome is defined as the total amount of days of absences from the day care centre during the study, due to the presence of episodes of URTI.
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Time frame: 10 days