Trials / Completed
CompletedNCT01044030
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- Boston Children's Hospital · Academic / Other
- Sex
- All
- Age
- 6 Months – 5 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xylitol syrup | 7.5 mL (5 grams) by mouth three times daily |
| DRUG | Placebo | 7.5 mL by mouth three times daily |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2010-01-07
- Last updated
- 2018-06-20
- Results posted
- 2015-03-20
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01044030. Inclusion in this directory is not an endorsement.