Treatment of acute otitis media with an antiadhesive oligosaccharide: a randomised, double-blind, placebo-controlled trial

Background Antiadhesive compounds are promising candidates for prevention o r treatment of infections. We have investigated the efficacy of such an age nt, 3'-sialyllacto-N-neotetraose (NE-1530), given intranasally far prophyla xis of acute otitis media and for effect on nasopharyngeal carriage of bact eria. Methods We did a randomised, double-blind placebo-controlled study at one s tudy site. 507 healthy children were randomly assigned either NE-1530 (n=25 4) or placebo (253) as intranasal sprays twice daily during 3 months. The c hildren were examined by the study physicians once a month and during illne ss. Treatment efficacy was estimated from Cox proportional hazards model. A sample of nasopharyngeal secretion was taken at every visit for culture of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhali s. Adverse events were recorded in study diaries. Findings At least one event of acute otitis media was diagnosed in 108 (43% ) of 254 children in the NE-1530 group and in 86 (34%) of 253 children in t he placebo group. The efficacy of treatment was negative, -27% (95% CI -68 to 5; p=0.10). The nasopharyngeal carriage of Streptococcus pneumoniae, Hae mophilus influenzae, and M catarrhalis was not affected by treatment, and t he adverse event profiles were almost identical for NE-1530 and placebo. Interpretation NE-1530 did not have a beneficial effect on the occurrence o f acute otitis media or on the nasopharyngeal carriage of bacteria in child ren.