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

XylitolBackground

Xylitol is a naturally occurring sugar alcohol with antibacterial properties.  In studies in Finland, xylitol has been shown to prevent acute otitis media (AOM) when given to young children as a gum or syrup five times a day.  The Xylitol Study is a clinical trial that was conducted in the U.S. by researchers from Slone Epidemiology Center and Children’s Hospital Boston.

The study was fielded within two major pediatric primary-care research networks: the Pediatric Physicians’ Organization at Children’s (PPOC) and the Slone Center Office-based Research (SCOR) Network.  The SCOR Network, is a national network of pediatricians and family practitioners who participate in research projects with investigators from the Slone Epidemiology Center. The PPOC Network is an affiliation of 72 private Massachusetts pediatric practices associated with Children’s Hospital Boston.

Objectives

The study was designed to determine the following:

  1. The effectiveness and safety of xylitol given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed AOM in children with a history of recurrent AOM.
  2. The effectiveness of xylitol in reducing antibiotic use in children with recurrent AOM.
  3. The effect of xylitol on nasopharyngeal and oropharyngeal colonization with Streptococcus pneumoniae and nontypeable Haemophilus influenzae, the two most important bacteria responsible for AOM.
  4. To compare the antimicrobial resistance patterns to antimicrobial agents commonly used to treat pediatric and adult respiratory tract infections of isolates of Streptococcus pneumoniae and nontypeable Haemophilus influenzae cultured from the oropharynx and/or nasopharynx of subjects treated with xylitol compared to placebo.

Results

This study is closed to enrollment.  Results are pending.

Investigators and Study Staff

Investigators:

Michael Corwin, M.D., Principal Investigator
Louis Vernacchio, M.D., M.Sc., Principal Investigator
Allen A. Mitchell, M.D., Co-Investigator
Stephen Pelton, M.D., Co-Investigator

Study Staff:

Fiona Rice, M.P.H., Project Coordinator
Katharine Mooney, Research Assistant
Rachel Burns, Research Assistant
Kathy Grellmann, R.N., Study Nurse
Maryellen McDonough, R.N., Study Nurse

Study Details

Sources of Funding:

  • National Institute for Deafness and Other Communication Disorders
  • Arbor Pharmaceuticals, Inc.

Study Period:

September 2009 to December 2011