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

Phase 3

Completed

• Conditions: Acute Otitis Media
• Interventions: Drug: Placebo; Drug: Xylitol syrup

• Registration Number: NCT01044030
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Study Start: 2010-02
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2015-03-10
• Results First Submitted QC: 2015-03-10
• Results First Posted: 2015-03-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Xylitol syrup	Xylitol syrup	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States

Slone Epidemiology Center at Boston University; 🇺🇸 Boston, Massachusetts, United States