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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Boston Children’s Hospital

Current Primary Outcome: Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media [ Time Frame: 12 weeks ]

Proportion of subjects who remained free of acute otitis media throughout the study period


Original Primary Outcome: To Determine the Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 12 weeks ]


Original Secondary Outcome:

  • To Determine the Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media [ Time Frame: 12 weeks ]
  • To Determine the Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae [ Time Frame: 12 weeks ]
  • To Compare the 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. [ Time Frame: 12 weeks ]


Information By: Boston Children’s Hospital

Dates:
Date Received: January 6, 2010
Date Started: February 2010
Date Completion:
Last Updated: April 8, 2015
Last Verified: April 2015