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BACKGROUND	Acute otitis media ( AOM ) is a common childhood illness and the leading indication for antibiotic prescriptions for US children .
BACKGROUND	Xylitol , a naturally occurring sugar alcohol , can reduce AOM when given 5 times per day as a gum or syrup , but a more convenient dosing regimen is needed for widespread adoption .
METHODS	We designed a pragmatic practice-based randomized controlled trial to determine if viscous xylitol solution at a dose of 5 g 3 times per day could reduce the occurrence of clinically diagnosed AOM among otitis-prone children 6 months through 5 years of age .
RESULTS	A total of 326 subjects were enrolled , with 160 allocated to xylitol and 166 to placebo .
RESULTS	In the primary analysis of time to first clinically diagnosed AOM episode , the hazard ratio for xylitol versus placebo recipients was 0.88 ( 95 % confidence interval [ CI ] 0.61 to 1.3 ) .
RESULTS	In secondary analyses , the incidence of AOM was 0.53 episodes per 90 days in the xylitol group versus 0.59 in the placebo group ( difference 0.06 ; 95 % CI -0.25 to 0.13 ) ; total antibiotic use was 6.8 days per 90 days in the xylitol group versus 6.4 in the placebo group ( difference 0.4 ; 95 % CI -1.8 to 2.7 ) .
RESULTS	The lack of effectiveness was not explained by nonadherence to treatment , as the hazard ratio for those taking nearly all assigned xylitol compared with those taking none was 0.93 ( 95 % CI 0.56 to 1.57 ) .
CONCLUSIONS	Viscous xylitol solution in a dose of 5 g 3 times per day was ineffective in reducing clinically diagnosed AOM among otitis-prone children .

