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:

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

Source of Funding:

National Institute for Deafness and Other Communication Disorders

Study Period:

September 2002 – August 2004

Publications:

Link to PPL