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 |
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.
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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