Phase 3
N=326
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT01044030 ↗Enrolled (actual)
326
Serious AEs
1.5%
Results posted
Mar 2015
Primary outcome: Primary: Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media — 66.9; 63.3 percentage of particpants — p=0.6
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Xylitol syrup (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Boston Children's Hospital
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media |
66.9; 63.3 | 0.6 |
| SECONDARY Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media |
60.6; 56.0 | — |
| SECONDARY Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae |
30.4; 20.0 | — |
| SECONDARY Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. |
10; 7; 6; 10 | — |
| SECONDARY Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. |
10; 7; 6; 10 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01044030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.