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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Otitis Media

Intervention / Treatment
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* Drug: Xylitol syrup
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylitol syrup<br> | Drug: Xylitol syrup<br>* 7.5 mL (5 grams) by mouth three times daily<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 7.5 mL by mouth three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media | Proportion of subjects who remained free of acute otitis media throughout the study period | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media | Proportion of subjects with no antibiotic use during the study period | 12 weeks | 
| Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae | Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites | 12 weeks | 
| 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. | Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment | 12 weeks | 
| 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. | Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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otitis media, ear infection