title: Tolerability of oral xylitol solution in young children: implications for otitis media prophylaxis.
abstract: OBJECTIVE
  Xylitol, given as 2g orally five times-a-day, significantly reduces the incidence of acute otitis media (AOM) in children. A less frequent dosing schedule, if tolerable and efficacious, would promote the more widespread use of this treatment. We sought to determine the tolerability and acceptability in young children of oral xylitol solution at doses of 5g three times-a-day (TID) and 7.5g once daily (QD).
  
  
  METHODS
  The study was a 3-month randomized placebo-controlled trial of the tolerability and acceptability of oral xylitol solution in 120 children 6-36 months of age performed in the SCOR Network.
  
  
  RESULTS
  Study withdrawals and unscheduled medical visits for gastrointestinal complaints did not differ significantly among the study groups. The proportions of subjects in the xylitol TID group who experienced excessive gas or diarrhea at months 1, 2, and 3 were 22.7%, 10.0%, and 14.3%, respectively, and in the xylitol QD group were 27.3%, 17.4%, and 14.3%, respectively, and these did not differ from the placebo groups. The proportions who accepted the study solution easily or with only minor difficulty at 1, 2, and 3 months in the xylitol TID group were 77.3%, 90.0%, and 90.5% and in the xylitol QD group, 77.3%, 82.6%, and 90.5%, respectively.
  
  
  CONCLUSIONS
  Oral xylitol solution at dosages of 5g TID and 7.5g QD is well-tolerated by young children. Given the potential for xylitol as a safe, inexpensive option for AOM prophylaxis, clinical trials using these dosages of xylitol can be conducted.
authors.affiliation: Slone Epidemiology Center at Boston University, Boston, MA 02215, USA. lvernacchio@slone.bu.edu
authors.forename: Louis
authors.initials: L
authors.lastname: Vernacchio
authors.forename: Richard M
authors.initials: RM
authors.lastname: Vezina
authors.forename: Allen A
authors.initials: AA
authors.lastname: Mitchell
mesh_terms: D000284:Administration, Oral; D002675:Child, Preschool; D003967:Diarrhea / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005414:Flatulence / Q000139:chemically induced; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000517:prevention & control*; D010865:Pilot Projects; D013549:Sweetening Agents / Q000008:administration & dosage* / Q000009:adverse effects; D014993:Xylitol / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D013549:Sweetening Agents; D014993:Xylitol