OM-85 BV for primary prevention of recurrent airway infections: a pilot randomized, double-blind, placebo-controlled study

• Autor(a) principal: Souza,Fátima Cleonice de
• Data de Publicação: 2020
• Outros Autores: Mocellin,Magáli, Ongaratto,Renata, Leitão,Lidiane Alves de Azeredo, Friedrich,Frederico Orlando, Silveira,Victória d’A, Scotta,Marcelo Comerlato, Pitrez,Paulo Márcio, Pinto,Leonardo Araújo
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Einstein (São Paulo)
• Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1679-45082020000100240
• topic: Respiratory tract infections/drug therapy; Placebo; Adjuvants, immunologic/therapeutic use; Child; Primary prevention

ABSTRACT Objective To compare the frequency of respiratory tract infections in children treated with OM-85 BV and placebo during the 3-month therapy period, and observation for a further 3 months after treatment. Methods A randomized, double-blind, placebo-controlled trial was conducted with 54 children (6 months to 5 years old) with no past history of recurrent respiratory infections attending daycare center. Family members were instructed to administer one capsule per day for 10 consecutive days, for 3 months of OM-85 BV or placebo. Telephone interviews were conducted every 30 days. Results There was no significant difference in the number of respiratory infections between the groups. The mean number of respiratory tract infection in the OM-85 BV Group in the first 3 months was 0.92±0.87, and in the Placebo Group was 0.74±1.02, and at 6 months it was 1.62±1.47 and 1.03±1.34, respectively. Conclusion OM-85 BV was not effective in the primary prevention of respiratory tract infections. Although most authors recommend the use of this immunostimulant in children with a history of recurrent respiratory infections, more studies are needed to define its usefulness in the primary prevention of respiratory infections in healthy children exposed to few risk factors.