STIMULATION OF NONSPECIFIC IMMUNITY TO REDUCE THE RISK OF RECURRENT INFECTIONS IN CHILDREN ATTENDING DAY-CARE-CENTERS

A randomized, double blind, placebo-controlled clinical trial was perf ormed in 423 children attending day-care centers to assess whether sti mulating nonspecific immunity would reduce the incidence of recurrent infections. The drug used for the trial (Imocur(R)) is an extract obta ined from eight different species of bacteria. At the end of the total follow-up period (3 months with treatment and 4.5 months without), th e risk for greater-than-or-equal-to 4 episodes of upper respiratory in fections was not significantly lower in the treated group than in the placebo group (26.7% vs. 33.8%, relative risk, 0.79; 95% confidence in terval, 0.59 to 1.06). In an exploratory analysis limited to the 3-mon th treatment period, however, we observed a 48% reduction in the risk of presenting greater-than-or-equal-to 3 episodes of upper respiratory infections: 9.5% vs. 18.3%, respectively, in the treatment group and the placebo group (relative risk, 0.52; 95% confidence interval, 0.31 to 0.86). Similar results were found for the risk of greater-than-or-e qual-to 1 episode of gastroenteritis. We also observed a strong correl ation between the drug efficacy and age; this observation is coherent with the underlying pathophysiologic model in which the immune system matures with age.