This study investigates the effect of Lactobacillus reuteri probiotic strains (DSM 17938 and L. reuteri DSM 33633) on symptoms of viral upper-respiratory tract infections in children.
Children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain)
Any gender
Age from 4 years to 17 years
Signing a informed consent form by at least one parent, foster parent or guardian after patient information and by children aged over 6 years
Use of antibiotics or probiotics in the 10 days prior to study enrolment
Use of a probiotic other than the test sample during the study
Eight or more otitis media within 12 months
Two or more bacterial sinusitis within 12 months
Parallel
Probiotics (L. reuteri DSM 17938 and L. reuteri DSM 33633)
Dietary supplementProbiotics drops (L. reuteri DSM 17938 and L. reuteri DSM 33633) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension.
Placebo
Other interventionPlacebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.
Percent of observation periods with absence of symptoms in children 4 years to 17 years old with symptoms of viral upper-respiratory tract infection
Duration of symptoms
Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough) measured from baseline and to end of intervention (14 completed days of intervention).
Severity of symptoms
Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough), recorded in a "Symptom Diary" based on the clinically validated "Wisconsin Upper Respiratory Symptom Survey 11" (WURSS-11), but modified according to the study's characteristics.
Duration of fever
Duration of fever, defined as the total number of hours that the child has a core temperature \>38oC measured twice per day measured from baseline and to end of intervention (14 completed days of intervention).
Amount of anti-pyretic and analgesic medication
Amount of anti-pyretic and analgesic medication, such as NSAIDs used from baseline and to end of intervention (14 completed days of intervention)
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Milosevits Gergely
Lead sponsor
Szent Miklós Szolgálat Kft.
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
