Acute Otitis Media, Dental Caries in Children, URTI
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERXylitol syrup
Each dose will be 5 mL of 400 g/L and subjects will receive Three to 5 doses will be given each day.
OTHERPlacebo
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.
Sponsors
The Hospital for Sick Children
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will be randomized to the treatment arm or control arm and will receive the study product or placebo.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 4 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| acute otitis media episodes | 6 months | Total number of physician diagnosed acute otitis media episodes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| upper respiratory tract infection episodes | 6 months | Total number of parent or caregiver reported upper respiratory tract infection episodes |
| dental caries | 6 months | absence of dental caries by parent report |
Other
| Measure | Time frame | Description |
|---|---|---|
| costs to parents including costs associated with attending medical appointments related to acute otitis media and lost productivity | 6 months | the costs of attending medical appointment will include the cost of transportation and the mode of transportation will be asked during a monthly call |
Countries
Canada
Contacts
Primary ContactChristine Kowal, MSc
Backup ContactDalah Mason, MPH
Outcome results
None listed