The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,003
Oral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach * First month: 4 consecutive days per week during 3 consecutive weeks * 5 next months: 4 consecutive days per month at monthly intervals
Oral administration - During 6 months : 1 sachet per day in the morning on an empty stomach * First month: 4 consecutive days per week during 3 consecutive weeks * 5 next months: 4 consecutive days per month at monthly intervals
Unnamed facility
Ancona, Italy
Unnamed facility
L’Aquila, Italy
Unnamed facility
Milan, Italy
Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2
Each URTI episodes will be medically assessed by the investigator by a thorough medical examination.
Time frame: at each infectious episode over year 2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Modena, Italy
Unnamed facility
Napoli, Italy
Unnamed facility
Roma, Italy
Unnamed facility
Varese, Italy
Unnamed facility
Kaunas, Lithuania
Unnamed facility
Panevezys, Lithuania
Unnamed facility
Vilnius, Lithuania
...and 14 more locations