Xylitol for the Prevention of Acute Otitis Media Episodes in Children (POME-Xylitol)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03055091|
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Otitis Media URTI Dental Caries in Children||Other: Xylitol syrup Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||472 participants|
|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.|
|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.|
|Official Title:||Xylitol for the Prevention of Acute Otitis Media Episodes in Children 2-4: A Pragmatic RCT|
|Actual Study Start Date :||March 31, 2017|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
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 Name: Sorbitol syrup
- acute otitis media episodes [ Time Frame: 6 months ]Total number of physician diagnosed acute otitis media episodes
- upper respiratory tract infection episodes [ Time Frame: 6 months ]Total number of parent or caregiver reported upper respiratory tract infection episodes
- dental caries [ Time Frame: 6 months ]absence of dental caries by parent report
- costs to parents including costs associated with attending medical appointments related to acute otitis media and lost productivity [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055091
|Contact: Christine Kowal, MSc||416-813-7654 ext firstname.lastname@example.org|
|Contact: Dalah Mason, MPH||416-813-7654 ext email@example.com|
|St Michael's Hospital||Recruiting|
|Toronto, Ontario, Canada, M5B 1X2|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 0A4|
|Principal Investigator:||Nav Persaud, MD||St. Michael's Hospital, Toronto|