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

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2012

Interventions

  • Drug: Xylitol syrup
    • 7.5 mL (5 grams) by mouth three times daily
  • Drug: Placebo
    • 7.5 mL by mouth three times daily

Arms, Groups and Cohorts

  • Experimental: Xylitol syrup
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boston Children’s Hospital
  • Collaborator
    • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Louis Vernacchio, Principal Investigator – Boston Children’s Hospital
  • Overall Official(s)
    • Louis Vernacchio, MD, MSc, Principal Investigator, Boston Children’s Hospital

References

Vernacchio L, Vezina RM, Mitchell AA. Tolerability of oral xylitol solution in young children: implications for otitis media prophylaxis. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):89-94. doi: 10.1016/j.ijporl.2006.09.008. Epub 2006 Nov 9.

Citations Reporting on Results

Vernacchio L, Corwin MJ, Vezina RM, Pelton SI, Feldman HA, Coyne-Beasley T, Mitchell AA. Xylitol syrup for the prevention of acute otitis media. Pediatrics. 2014 Feb;133(2):289-95. doi: 10.1542/peds.2013-2373. Epub 2014 Jan 6.

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