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| Name | Class |
|---|---|
| The Hospital for Sick Children | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Participants in the treatment arm will receive a Xylitol syrup. |
|
| Placebo | Placebo Comparator | Participants in the placebo arm will receive sorbitol syrup. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylitol syrup | Other | Each dose will be 5 mL of 400 g/L and subjects will receive Three to 5 doses will be given each day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| acute otitis media episodes | Total number of physician diagnosed acute otitis media episodes | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| upper respiratory tract infection episodes | Total number of parent or caregiver reported upper respiratory tract infection episodes | 6 months |
| dental caries | absence of dental caries by parent report |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Kowal, MSc | Contact | 416-813-7654 | 309441 | christine.kowal@sickkids.ca |
| Dalah Mason, MPH | Contact | 416-813-7654 | 302129 | dalah.mason@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nav Persaud, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1X2 | Canada | |
| The Hospital for Sick Children |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37890960 | Derived | Persaud N, Azarpazhooh A, Keown-Stoneman C, Birken CS, Isaranuwatchai W, Maguire JL, Mamdani M, Allen C, Mason D, Kowal C, Jaleel M, Bazeghi F, Thorpe KE, Laupacis A, Parkin PC. Xylitol for the prevention of acute otitis media episodes in children aged 1-5 years: a randomised controlled trial. Arch Dis Child. 2024 Jan 22;109(2):121-124. doi: 10.1136/archdischild-2023-325565. | |
| 30082349 |
| Label | URL |
|---|---|
| The Applied Research Group | View source |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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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.
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Participants will be randomized to the treatment arm or control arm and will receive the study product or placebo.
| Placebo | Other | 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. |
|
|
| 6 months |
| Recruiting |
| Toronto |
| Ontario |
| M5G 0A4 |
| Canada |
| Derived |
| Persaud N, Laupacis A, Azarpazhooh A, Birken C, Hoch JS, Isaranuwatchai W, Maguire JL, Mamdani MM, Thorpe K, Allen C, Mason D, Kowal C, Bazeghi F, Parkin P; TARGet Kids! Collaboration. Xylitol for the prevention of acute otitis media episodes in children aged 2-4 years: protocol for a pragmatic randomised controlled trial. BMJ Open. 2018 Aug 5;8(8):e020941. doi: 10.1136/bmjopen-2017-020941. |