Objective. As regular administration of xylitol had been effective in preventing acute otitis media (AOM) in children, we tested whether xylitol administered only at times of acute respiratory infection (ARI) reduces the occurrence of AOM.

Methods. Healthy children (N = 1277) were recruited from child care centers and randomized after screening with tympanometry to receive either control mixture (n = 212), xylitol mixture (n = 212), control chewing gum (n = 280), xylitol chewing gum (n = 286), or xylitol lozenges (n = 287) during an ARI. The trial was randomized and double blinded within the mixture and chewing gum groups. The parents began administering the products to their children at the onset of symptoms of ARI. The follow-up lasted until resolution of the symptoms or up to 3 weeks.

Results. A total of 1253 of the 1277 randomized children were eligible for the analysis. Altogether, 980 (78%) of 1253 children had at least 1 episode of ARI during the 4 months that the trial lasted. The occurrence of AOM during this episode was 34 (20.5%) of 166 in the xylitol mixture group, as compared with 32 (20.4%) of 157 among the children who received the control mixture. Among the older children who received control chewing gum, xylitol chewing gum, or xylitol lozenges, AOM was experienced by 24 (11.0%) of 218, 31 (14.1%) of 220, and 34 (15.5%) of 219, respectively. None of the differences between the groups was statistically significant.

Conclusions. Xylitol administered only during an ARI was ineffective in preventing AOM.

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