Xylitol for the Prevention of Acute Otitis Media Episodes in Children (POME-Xylitol)

This is a randomized controlled trial of regular daily use of xylitol (or "birch sugar"), a natural sweetener that has antimicrobial properties, for the prevention of acute otitis media (AOM, primary outcome) as well as upper respiratory tract infections and dental caries (the two secondary outcomes) in preschool aged children. This trial will be conducted through the TARGet Kids! research network.

This is an RCT of regular daily use of xylitol (or "birch sugar"), a natural sweetener that has antimicrobial properties, for the prevention of acute otitis media (AOM, primary outcome) as well as upper respiratory tract infections and dental caries (the two secondary outcomes) in preschool aged children. Clinical equipoise over the efficacy of xylitol in preventing AOM - a common and costly condition in early childhood - persists even after the completion of three RCTs by a single research group in Finland and one in the United States. Several clinical trials of xylitol for the prevention of dental caries and other studies have demonstrated that the intervention in this trial (3-5 doses of xylitol per day) is safe, well tolerated and feasible for the study period. This trial will be conducted through the TARGet Kids! research network which is undertaking several CIHR funded RCTs and will leverage existing CIHR funded infrastructure and important collaborations. The nominated principal applicant's salary is supported by a CIHR RCT training grant to develop this RCT under the mentorship of a co-principal applicant who is an experienced trialist. This trial has the potential to transform the management of three common conditions during early childhood from treatment to prevention using a currently underutilized antimicrobial substance.

This will be a pragmatic triple blind (participant and parents, practitioners and analyst will be blinded), two arm, superiority, placebo controlled randomized trial with 1:1 allocation.

Participants will be randomized to the treatment arm or control arm and will receive the study product or placebo.

Each dose looks and tastes like the xylitol syrup but it is not microbial. Each dose will be 5 mL of 300 g/L of sorbitol. Three to 5 doses will be given each day.

costs to parents including costs associated with attending medical appointments related to acute otitis media and lost productivity

the costs of attending medical appointment will include the cost of transportation and the mode of transportation will be asked during a monthly call

Inclusion Criteria: Children already enrolled in the TARGet Kids! Network, age 2 - 4 years at start of intervention, parents or care provider able to give consent, able to understand the information in English. Exclusion Criteria: craniofacial malformations, structural middle ear abnormalities, sibling or any other child living at the same address already enrolled in the trial, insertion of ventilation tubes prior to study period, current use of a xylitol product or reported xylitol sensitivity.

Persaud N, Laupacis A, Azarpazhooh A, Birken C, Hoch JS, Isaranuwatchai W, Maguire JL, Mamdani MM, Thorpe K, Allen C, Mason D, Kowal C, Bazeghi F, Parkin P; TARGet Kids! Collaboration. Xylitol for the prevention of acute otitis media episodes in children aged 2-4 years: protocol for a pragmatic randomised controlled trial. BMJ Open. 2018 Aug 5;8(8):e020941. doi: 10.1136/bmjopen-2017-020941.