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

Fátima Cleonice de Souza1, Magáli Mocellin2, Renata Ongaratto2

  • 1Universidade de Santa Cruz do Sul , Santa Cruz do Sul , RS , Brazil .

Einstein (Sao Paulo, Brazil)
|March 5, 2020
PubMed

Insights

OM-85 BV did not significantly reduce respiratory infections in healthy children. This immunostimulant showed no benefit in preventing infections during a 6-month study period.

Area of Science:

  • Pediatrics
  • Immunology
  • Infectious Diseases

Background:

  • Respiratory tract infections (RTIs) are common in young children attending daycare.
  • The immunostimulant OM-85 BV is often recommended for children with recurrent RTIs.
  • Its efficacy in primary prevention for healthy children is less understood.

Purpose of the Study:

  • To evaluate the effectiveness of OM-85 BV in preventing RTIs in healthy children.
  • To compare RTI frequency between children receiving OM-85 BV and placebo.
  • To assess outcomes during a 3-month treatment and a subsequent 3-month observation period.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial.
  • Involved 54 children aged 6 months to 5 years attending daycare.
  • Participants received daily OM-85 BV or placebo for 3 months, with follow-up for 6 months.

Main Results:

  • No significant difference in the number of RTIs between the OM-85 BV and placebo groups.
  • Mean RTIs at 3 months: 0.92 (OM-85 BV) vs. 0.74 (placebo).
  • Mean RTIs at 6 months: 1.62 (OM-85 BV) vs. 1.03 (placebo).

Conclusions:

  • OM-85 BV was not effective for the primary prevention of RTIs in this cohort.
  • Further research is needed to clarify its role in primary prevention for healthy children.
  • Current recommendations for OM-85 BV primarily target children with a history of recurrent RTIs.
Abstract

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