Xylitol for the Prevention of Acute Otitis Media in Children (Feasibility Study)

Objectives

The study had three main objectives: 1) To assess the tolerability of varying doses and administration schedules of oral xylitol solution in young children; 2) to evaluate the compliance and side effect profiles of once daily and three-times-a-day dosing schedules of oral xylitol solution given to young children for three months; 3) to assess the feasibility of enrolling and following appropriate subjects, refine data collection procedures and instruments, and consider whether it is feasible to conduct a large national randomized controlled trial.

Methods

The study was conducted through the Slone Center Office-based Research (SCOR) Network, a national network of pediatricians and family practitioners who participate in research projects with investigators from the Slone Epidemiology Center.

Participating physician-investigators from the SCOR Network identified children who meet the eligibility criteria and obtain written informed consent. For Phase 1, subjects were randomized to one of various doses and administration schedules of xylitol or control solution, and adverse events were reported by means of a daily diary over a seven-day period. For Phase 2, subjects were randomized to once daily or three-times-a-day xylitol or control solution and monitored for three months for compliance, adverse effects, and episodes of otitis media

Results

Xylitol solution at doses of five grams three times a day and 7.5 grams once daily were well tolerated by children between the ages of six months and three years old.

Investigators and Study Staff

Louis Vernacchio, M.D., M.Sc., Principal Investigator
Allen Mitchell, M.D., Co-Investigator

Study Details

Source of Funding:

National Institute for Deafness and Other Communication Disorders

Study Period:

September 2002 to August 2004

Publications

  • Vernacchio L, Mitchell AA. Xylitol to prevent acute otitis media [letter to the editor]. Pediatr Infect Dis J 2007;26(9):863-4.
  • Vernacchio L, Vezina RM, Mitchell AA.  Management of acute otitis media by primary care physicians: trends since the release of the 2004 American Academy of Pediatrics/American Academy of Family Physicians Clinical Practice Guideline.  Pediatrics 2007;120(2);281-7.
  • Vernacchio L, Vezina RM, Ozonoff AA, Mitchell AA. Validity of parental reporting of recent episodes of acute otitis media: a Slone Center Office-based Research (SCOR) Network study. J Am Board Fam Med 2007;20:160-3.
  • Vernacchio L, Vezina RM, Mitchell AA.  Tolerability of oral xylitol solution in young children: implications for otitis media prophylaxis.  Int J Pediatr Otorhinolaryngol 2007;71(1):89-94.
  • Vernacchio L, Vezina RM, Mitchell AA. Knowledge and practices relating to the 2004 Acute Otitis Media Clinical Practice Guideline: a survey of practicing physicians. Pediatr Infect Dis J 2006;25:385-9.