Xylitol for the Prevention of Acute Otitis Media Episodes in Children

Last updated: September 5, 2019
Sponsor: St. Michael's Hospital, Toronto
Overall Status: Active - Recruiting

Phase

N/A

Condition

Otitis Media

Otitis (Pediatric)

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT03055091
16-300
  • Ages 2-4
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children already enrolled in the TARGet Kids! Network, age 2 - 4 years at start ofintervention, parents or care provider able to give consent, able to understand theinformation in English.

Exclusion

Exclusion Criteria:

  • craniofacial malformations, structural middle ear abnormalities, sibling or any otherchild living at the same address already enrolled in the trial, insertion ofventilation tubes prior to study period, current use of a xylitol product or reportedxylitol sensitivity.

Study Design

Total Participants: 472
Study Start date:
March 31, 2017
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • St Michael's Hospital

    Toronto, Ontario M5B 1X2
    Canada

    Active - Recruiting

  • The Hospital for Sick Children

    Toronto, Ontario M5G 0A4
    Canada

    Active - Recruiting

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