Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RC1DC010668-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear infection) in children with a history of recurrent acute otitis media.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xylitol syrup | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylitol syrup | Drug | 7.5 mL (5 grams) by mouth three times daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media | Proportion of subjects who remained free of acute otitis media throughout the study period | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media | Proportion of subjects with no antibiotic use during the study period | 12 weeks |
| Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Louis Vernacchio, MD, MSc | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Boston | Boston | Massachusetts | 02115 | United States | ||
| Slone Epidemiology Center at Boston University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17097152 | Background | Vernacchio L, Vezina RM, Mitchell AA. Tolerability of oral xylitol solution in young children: implications for otitis media prophylaxis. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):89-94. doi: 10.1016/j.ijporl.2006.09.008. Epub 2006 Nov 9. | |
| 24394686 | Result | Vernacchio L, Corwin MJ, Vezina RM, Pelton SI, Feldman HA, Coyne-Beasley T, Mitchell AA. Xylitol syrup for the prevention of acute otitis media. Pediatrics. 2014 Feb;133(2):289-95. doi: 10.1542/peds.2013-2373. Epub 2014 Jan 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Xylitol Syrup | Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily |
| FG001 | Placebo | Placebo: 7.5 mL by mouth three times daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Xylitol Syrup | Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily |
| BG001 | Placebo | Placebo: 7.5 mL by mouth three times daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media | Proportion of subjects who remained free of acute otitis media throughout the study period | Posted | Number | percentage of particpants | 12 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xylitol Syrup | Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tympanostomy tube insertion and adenoidectomy | Ear and labyrinth disorders | MedDRA (Unspecified) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Louis Vernacchio, MD, MSc | Boston Children's Hospital | 617-919-4283 | louis.vernacchio@childrens.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
7.5 mL by mouth three times daily |
|
Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites |
| 12 weeks |
| Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. | Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment | 12 weeks |
| Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. | Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment | 12 weeks |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Participants |
|
|
|
| Secondary | Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media | Proportion of subjects with no antibiotic use during the study period | Posted | Number | percentage of participants | 12 weeks |
|
|
|
| Secondary | Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae | Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites | This outcome measure is limited to those subjects enrolled in the local enrolling sites only. | Posted | Number | percentage of participants | 12 weeks |
|
|
|
| Secondary | Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. | Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Antimicrobial Resistance Patterns of Isolates of Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae Cultured From the Oropharynx and/or Nasopharynx of Subjects Treated With Viscous-adherent Xylitol Compared to Placebo. | Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| 4 |
| 160 |
| 89 |
| 160 |
| EG001 | Placebo | Placebo: 7.5 mL by mouth three times daily | 1 | 166 | 93 | 166 |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (Unspecified) |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| Abscess | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
|
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
|
Not provided
Not provided