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 : August 14, 2017
|Condition or disease||Intervention/treatment|
|Acute Otitis Media URTI Dental Caries in Children||Other: Xylitol syrup Other: Placebo|
|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 :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
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
- AOM episodes [ Time Frame: Up to 6 months ]Total number of physician diagnosed AOM episodes
- URTI episodes and dental caries [ Time Frame: Up to 6 months ]Total number of parent/caregiver reported Upper Respiratory Tract Infection (URTI) episodes or absence of dental caries by parent report.
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 email@example.com|
|Contact: Dalah Mason, MPH||416-813-7654 ext firstname.lastname@example.org|
|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|