Acute Otitis Media
Conditions
Keywords
otitis media, ear infection
Brief summary
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.
Interventions
DRUGXylitol syrup
7.5 mL (5 grams) by mouth three times daily
DRUGPlacebo
7.5 mL by mouth three times daily
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Six months to five years of age * General good health * History of at least three episodes of AOM in previous 12 months, at least one of which occurred within the previous six months * English or Spanish speaking
Exclusion criteria
* History of tympanostomy tubes * Intestinal malabsorption or chronic diarrhea * Diabetes mellitus * Any inborn error of metabolism * Parent/guardian unreachable by telephone * Known allergy to any of the study solution components (xylitol, sorbitol, sodium carboxymethylcellulose, potato starch, glycerin, potassium sorbate, natural berry flavoring).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media | 12 weeks | Proportion of subjects who remained free of acute otitis media throughout the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media | 12 weeks | Proportion of subjects with no antibiotic use during the study period |
| Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae | 12 weeks | Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites |
| 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. | 12 weeks | Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Xylitol Syrup Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily | 160 |
| Placebo Placebo: 7.5 mL by mouth three times daily | 166 |
| Total | 326 |
Baseline characteristics
| Characteristic | Placebo | Total | Xylitol Syrup |
|---|---|---|---|
| Age, Continuous | 21.5 months STANDARD_DEVIATION 13.7 | 21.9 months STANDARD_DEVIATION 13.7 | 22.3 months STANDARD_DEVIATION 13.7 |
| Race/Ethnicity, Customized Black, non-Hispanic | 8 participants | 15 participants | 7 participants |
| Race/Ethnicity, Customized Hispanic | 22 participants | 47 participants | 25 participants |
| Race/Ethnicity, Customized Other/Refused/unknown | 22 participants | 40 participants | 18 participants |
| Race/Ethnicity, Customized White, non-Hispanic | 114 participants | 224 participants | 110 participants |
| Sex: Female, Male Female | 73 Participants | 140 Participants | 67 Participants |
| Sex: Female, Male Male | 93 Participants | 186 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 89 / 160 | 93 / 166 |
| serious Total, serious adverse events | 4 / 160 | 1 / 166 |
Outcome results
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
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xylitol Syrup | Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media | 66.9 percentage of particpants |
| Placebo | Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media | 63.3 percentage of particpants |
p-value: 0.6Chi-squared
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
Time frame: 12 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Xylitol Syrup | 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. | Resistant | 5 Participants |
| Xylitol Syrup | 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. | Sensitive | 12 Participants |
| Placebo | 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. | Sensitive | 8 Participants |
| Placebo | 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. | Resistant | 6 Participants |
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
Time frame: 12 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Xylitol Syrup | 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. | Resistant | 10 Participants |
| Xylitol Syrup | 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. | Sensitive | 6 Participants |
| Placebo | 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. | Resistant | 7 Participants |
| Placebo | 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. | Sensitive | 10 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
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xylitol Syrup | Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media | 60.6 percentage of participants |
| Placebo | Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media | 56.0 percentage of participants |
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
Time frame: 12 weeks
Population: This outcome measure is limited to those subjects enrolled in the local enrolling sites only.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Xylitol Syrup | Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae | 30.4 percentage of participants |
| Placebo | Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae | 20.0 percentage of participants |