drugset / Trial / NCT01044030
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
Phase 3
Completed
326 enrolled
Boston Children's Hospital
National Institute on Deafness and Other Communication Disorders (NIDCD) · collab
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2010-02
- Primary completion
- 2012-06
- Completion
- 2012-06
Outcome
Missed primary endpoint
paper hazard ratio for xylitol versus placebo recipients was 0.88 (95% confidence interval [CI] 0.61 to 1.3). PMID 24394686 ↗
paper CONCLUSIONS: Viscous xylitol solution in a dose of 5 g 3 times per day was ineffective in reducing clinically diagnosed AOM among otitis-prone children. PMID 24394686 ↗
Publications
- Background Vernacchio L, Vezina RM, Mitchell AA. Tolerability of oral xylitol solution in young children: implications for otitis media prophylaxis. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):89-94. doi: 10.1016/j.ijporl.2006.09.008. Epub 2006 Nov 9.
- Results Vernacchio L, Corwin MJ, Vezina RM, Pelton SI, Feldman HA, Coyne-Beasley T, Mitchell AA. Xylitol syrup for the prevention of acute otitis media. Pediatrics. 2014 Feb;133(2):289-95. doi: 10.1542/peds.2013-2373. Epub 2014 Jan 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Xylitol | Small molecule | 5 g | Oral |