POME-Xylitol: Xylitol for the Prevention of Acute Otitis Media Episodes in Children

Sponsor

Unity Health Toronto (Other)

Overall Status

Unknown status

CT.gov ID

NCT03055091

Collaborator

The Hospital for Sick Children (Other)

472

Enrollment

Locations

Arms

Anticipated Duration (Months)

236

Patients Per Site

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Otitis Media URTI Dental Caries in Children	Other: Xylitol syrup Other: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

472 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Participants will be randomized to the treatment arm or control arm and will receive the study product or placebo.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 31, 2017

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group Participants in the treatment arm will receive a Xylitol syrup.	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 Comparator: Placebo Participants in the placebo arm will receive sorbitol syrup.	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. Other Names: Sorbitol syrup

Arm

Intervention/Treatment

Experimental: Treatment group

Participants in the treatment arm will receive a Xylitol syrup.

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 Comparator: Placebo

Participants in the placebo arm will receive sorbitol syrup.

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.

Other Names:

Sorbitol syrup

Outcome Measures

Primary Outcome Measures

acute otitis media episodes [6 months]
Total number of physician diagnosed acute otitis media episodes

Secondary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 4 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Michael's Hospital	Toronto	Ontario	Canada	M5B 1X2
2	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 0A4

Sponsors and Collaborators

Unity Health Toronto
The Hospital for Sick Children

Investigators

Principal Investigator: Nav Persaud, MD, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

The Applied Research Group

Publications

None provided.

Responsible Party:

Unity Health Toronto

ClinicalTrials.gov Identifier:

NCT03055091

Other Study ID Numbers:

16-300

First Posted:

Feb 16, 2017

Last Update Posted:

Sep 6, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 6, 2019