Recruiting

Xylitol

Sponsor:

Unity Health Toronto

Code:

NCT03055091

Conditions

Acute Otitis Media

URTI

Dental Caries in Children

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

Interventions

Xylitol syrup

Placebo

Study Details

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.

Conditions

Acute Otitis Media

URTI

Dental Caries in Children

Study ID

NCT03055091

Start date

Mar 31, 2017

Status verified date

Sep, 2019

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Jun 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 4

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

472 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment group

Participants in the treatment arm will receive a Xylitol syrup.

placebo comparator: Placebo

Participants in the placebo arm will receive sorbitol syrup.

Interventions

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.

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.

Primary outcome measure

  • acute otitis media episodes [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Christine Kowal, MSc

416-813-7654christine.kowal@sickkids.ca

Dalah Mason, MPH

416-813-7654dalah.mason@sickkids.ca

Locations

St Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1X2

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 0A4

More Information

Sponsor

Unity Health Toronto

Last update posted

Sep 6, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2019-09-06.