Conditions: Acute Otitis Media
Keywords: otitis media ear infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 326
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Xylitol syrup intervention 2: Placebo
Intervention descriptions: intervention 1: 7.5 mL (5 grams) by mouth three times daily intervention 2: 7.5 mL by mouth three times daily

Protocol document: