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A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections

Journal of Translational Medicine Sep 01, 2019

Esposito S, Bianchini S, Bosis S, et al. - Via a randomized, placebo-controlled, double-blind, single-centre, phase IV trial conducted in Italy, researchers further added to the assessment of the role played by OM-85, a lysate of 21 common bacterial respiratory pathogens, in the prevention of recurrent respiratory tract infections (RTIs) in children. Among patients receiving OM-85 for 3 months vs those given placeboes, the number of RTIs and of children who experienced at least one RTI were significantly lower. For upper RTIs, variations were statistically important. In the group with children treated with OM-85 for 3 months vs the placebo group, days of absence from daycare for children and working days lost by parents were significantly lower. Among children who received OM-85 for 3 and those who received OM-85 for 6 months, no variation was observed. The results were not impacted by the prevalence of atopy, as well as the history of recurrent wheezing and the age of the study child. Among children with a history of repeated recurrences, the advantage was maximally evident. Even in children who received an influenza vaccination, OM-85 was well-tolerated and safe. Therefore, in children, with a favorable safety profile, the use of OM-85 for 3 months in 3 series of 10 consecutive days each time diminishes the risk of recurrent RTIs. The higher impact noted in children prone to several respiratory episodes vs non-prone children appears to intimate that this lysate should be administered particularly to children with a proven high susceptibility to RTIs.
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