NCT03055091

Xylitol for the Prevention of Acute Otitis Media Episodes in Children

Xylitol for the Prevention of Acute Otitis Media Episodes in Children 2-4: A Pragmatic RCT

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 472 (estimated)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 2 Years – 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Otitis Media
• URTI
• Dental Caries in Children

Interventions

Type	Name	Description
OTHER	Xylitol syrup	Each dose will be 5 mL of 400 g/L and subjects will receive Three to 5 doses will be given each day.
OTHER	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.

Timeline

• Start date: 2017-03-31
• Primary completion: 2021-06-30
• Completion: 2021-12-31
• First posted: 2017-02-16
• Last updated: 2019-09-06

Locations

2 sites across 1 country: Canada