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

Fátima Cleonice De Souza,Frederico Orlando Friedrich,Paulo Márcio Pitrez,Magáli Mocellin,Marcelo Comerlato Scotta,Leonardo Araújo Pinto,Lidiane Alves De Azeredo Leitão,Renata Ongaratto,Victória D’A Silveira

doi:10.31744/einstein_journal/2020ao5262

Abstract

ABSTRACTObjectiveTo 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.MethodsA 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.ResultsThere 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.ConclusionOM-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.

Highlights

Respiratory tract infections (RTIs) are a major cause of childhood morbidity and mortality
It is widely accepted that the recurrence of RTI increases the predisposition to future respiratory problems.[7,8] Repeated lower RTI in the first 3 years of life have a positive association with wheezing until the age of 7 years.[9]. In addition to the preventive measures already proven to reduce recurrent respiratory infections (RRI), as promoting breastfeeding, adequate vaccination of children, vaccination of pregnant women, hygiene measures and tobacco-free environment, bacterial immunomodulators have been proposed as preventive intervention.[10,11]
Recurrent respiratory infections are common in pediatric healthy young patients, and may be triggered by different types of virus and bacteria.[11,14] In this study, with children without history of RRI, no beneficial effect was observed with the use of OM-85 BV

Summary

Introduction

Respiratory tract infections (RTIs) are a major cause of childhood morbidity and mortality. From the clinical point of view, studies have demonstrated safety and efficacy in use of bacterial immunostimulants.[14,15] In a systematic review, it was observed that children treated with OM-85 BV had significantly fewer cases of RRI. These data suggest that the effect is greater in patients with increased risk of RRI or higher number of RRI prior to inclusion in the study.[16] The role of OM-85 BV in the primary prevention of respiratory infection still needs to be clarified

Methods

Results

Discussion

Conclusion