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An open, prospective trial was conducted to compare the efficacy of a bacterial extract (OM-85 BV) [;Broncho-Vaxom'] vs conventional management in the prevention of chronic, recurrent respiratory diseases in children. 61 children aged between 1 and 11 years who had presented three or more respiratory tract infections in the last 6 months were enrolled. 30 children (mean age 4.1 +/- 2.7 years) received one capsule a day of Broncho-Vaxom, 10 days a month, for 3 consecutive months, and 31 (mean age 3.8 +/- 2.0 years) received no Broncho-Vaxom and served as a control group. During the 6-month follow-up period, patients treated with Broncho-Vaxom showed a significant reduction in the average number of infections (2.25 +/- 0.58 vs 4.68 +/- 0.94, p < 0.05); they were ill a lesser number of days (11.8 +/- 3.67 vs 28.06 +/- 6.72, p < 0.05), were exposed to fewer antibacterial treatments (1.1 +/- 0.76 vs 2.52 +/- 0.85, p < 0.05), required less additional treatment with conventional drugs (2.17 +/- 0.59 vs 4.39 +/- 0.88, p < 0.05), and spent fewer days under treatment (14.27 +/- 7.27 vs 30 +/- 6.49, p < 0.05). In conclusion, Broncho-Vaxom appears to be a practical, safe option for lowering the incidence of respiratory tract infections in susceptible children.