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



Status:Completed
Conditions:Other Indications, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any - 5
Updated:6/22/2018
Start Date:February 2010
End Date:June 2012

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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).
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Boston, MA
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Boston, Massachusetts 02115
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Boston, MA
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