POME Xylitol: Xylitol for the Prevention of acute Otitis Media Episodes in children aged 2-4: A pragmatic RCT
Dr. Nav Persaud, St. Michael's Hospital
Xylitol (or “birch sugar”) is a naturally occurring sugar with antibacterial properties that has been used as a natural non-sugar sweetener in chewing gums, confectionery, toothpaste and medicines. Studies have shown that by age of 3 years, 84% of children have had at least one episode of middle ear infections and 46% have had 3 or more episodes. Previous studies have suggested that xylitol may be effective at decreasing the number of acute otitis media (ear infection) episodes in children up to 12 years of age when taken 5 times per day over a period of a few months. Several countries also recommend xylitol for the prevention of dental caries. Currently however, there is not enough research to recommend xylitol use in preschool children (ages 2-4 years old).
Objective and Trial Procedure
We are doing this research to find out if xylitol can help prevent acute otitis media and upper respiratory tract infections as well as dental caries. Since ear and upper respiratory tract infections are more common during the winter, this study will begin during the winter months.
Children who participate in this study will be randomly assigned (having an equal chance like the flip of a coin) to one of two study groups:
Xylitol group - take 1 teaspoon (5 mL) of syrup containing xylitol (400 g/L) 3-5 times per day for six months (preferably after meals).
Sorbitol group - take 1 teaspoon (5 mL) of syrup containing sorbitol (300 g/L) 3-5 times per day for six months (preferably after meals). Sorbitol is a sweetener that does not contain antimicrobial properties and used in this study as a ‘placebo’.
Research Assistants will contact participants once a month by telephone to obtain the study data.
Importance of the Trial
Acute otitis media, upper respiratory tract infections, and dental caries are all common and costly conditions in young children that could be prevented by regular xylitol use. Acute otitis media and upper respiratory tract infections are viewed as unavoidable during early childhood. This trial has the potential to transform the approach to three common conditions in Canada and around the world.