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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03055091
Other study ID # 16-300
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 31, 2017
Est. completion date December 31, 2021

Study information

Verified date September 2019
Source St. Michael's Hospital, Toronto
Contact Christine Kowal, MSc
Phone 416-813-7654
Email christine.kowal@sickkids.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 472
Est. completion date December 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 4 Years
Eligibility 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


Intervention

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.
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.

Locations

Country Name City State
Canada St Michael's Hospital Toronto Ontario
Canada The Hospital for Sick Children Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
St. Michael's Hospital, Toronto The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 6 months
Primary acute otitis media episodes Total number of physician diagnosed acute otitis media episodes 6 months
Secondary upper respiratory tract infection episodes Total number of parent or caregiver reported upper respiratory tract infection episodes 6 months
Secondary dental caries absence of dental caries by parent report 6 months
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