Xylitol for the Prevention of Acute Otitis Media Episodes in Children

Dental Caries in Children Clinical Trial

— POME-Xylitol  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03055091
• Other study ID #: 16-300
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Acute Otitis Media
• Dental Caries
• Dental Caries in Children
• Otitis
• Otitis Media
• URTI

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

External Links

•   The Applied Research Group