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

Boston Children's Hospital326 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

326

Conditions

Acute Otitis Media

Interventions

Xylitol syrupDRUG

7.5 mL (5 grams) by mouth three times daily

PlaceboDRUG

7.5 mL by mouth three times daily

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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).

Locations (2)

Children's Hospital Boston

Boston, Massachusetts, United States

Slone Epidemiology Center at Boston University

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment

Time frame: 12 weeks

Data from ClinicalTrials.gov

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