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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)

Criteria

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).