Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children

Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children

The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear infection) in children with a history of recurrent acute otitis media.

Inclusion Criteria:

• Six months to five years of age
• General good health
• History of at least three episodes of AOM in previous 12 months, at least one of which occurred within the previous six months
• English or Spanish speaking

Exclusion Criteria:

• History of tympanostomy tubes
• Intestinal malabsorption or chronic diarrhea
• Diabetes mellitus
• Any inborn error of metabolism
• Parent/guardian unreachable by telephone
• Known allergy to any of the study solution components (xylitol, sorbitol, sodium carboxymethylcellulose, potato starch, glycerin, potassium sorbate, natural berry flavoring).