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Trial record 6 of 433 for:    OTITIS

Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children

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ClinicalTrials.gov Identifier: NCT01044030
Recruitment Status : Completed
First Posted : January 7, 2010
Results First Posted : March 20, 2015
Last Update Posted : June 20, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Louis Vernacchio, Boston Children’s Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Acute Otitis Media
Interventions Drug: Xylitol syrup
Drug: Placebo
Enrollment 326
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Xylitol Syrup Placebo
Hide Arm/Group Description Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily Placebo: 7.5 mL by mouth three times daily
Period Title: Overall Study
Started 160 166
Completed 141 146
Not Completed 19 20
Arm/Group Title Xylitol Syrup Placebo Total
Hide Arm/Group Description Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily Placebo: 7.5 mL by mouth three times daily Total of all reporting groups
Overall Number of Baseline Participants 160 166 326
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 160 participants 166 participants 326 participants
22.3  (13.7) 21.5  (13.7) 21.9  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 166 participants 326 participants
Female
67
  41.9%
73
  44.0%
140
  42.9%
Male
93
  58.1%
93
  56.0%
186
  57.1%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 160 participants 166 participants 326 participants
White, non-Hispanic 110 114 224
Hispanic 25 22 47
Black, non-Hispanic 7 8 15
Other/Refused/unknown 18 22 40
1.Primary Outcome
Title Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xylitol Syrup Placebo
Hide Arm/Group Description:
Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
Placebo: 7.5 mL by mouth three times daily
Overall Number of Participants Analyzed 160 166
Measure Type: Number
Unit of Measure: percentage of particpants
66.9 63.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Xylitol Syrup, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media
Hide Description Proportion of subjects with no antibiotic use during the study period
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xylitol Syrup Placebo
Hide Arm/Group Description:
Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
Placebo: 7.5 mL by mouth three times daily
Overall Number of Participants Analyzed 160 166
Measure Type: Number
Unit of Measure: percentage of participants
60.6 56.0
3.Secondary Outcome
Title Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure is limited to those subjects enrolled in the local enrolling sites only.
Arm/Group Title Xylitol Syrup Placebo
Hide Arm/Group Description:
Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
Placebo: 7.5 mL by mouth three times daily
Overall Number of Participants Analyzed 23 20
Measure Type: Number
Unit of Measure: percentage of participants
30.4 20.0
4.Secondary Outcome
Title 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.
Hide Description Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xylitol Syrup Placebo
Hide Arm/Group Description:
Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
Placebo: 7.5 mL by mouth three times daily
Overall Number of Participants Analyzed 17 14
Measure Type: Count of Participants
Unit of Measure: Participants
Resistant
5
  29.4%
6
  42.9%
Sensitive
12
  70.6%
8
  57.1%
5.Secondary Outcome
Title 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.
Hide Description Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Xylitol Syrup Placebo
Hide Arm/Group Description:
Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
Placebo: 7.5 mL by mouth three times daily
Overall Number of Participants Analyzed 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
Resistant
10
  62.5%
7
  41.2%
Sensitive
6
  37.5%
10
  58.8%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Xylitol Syrup Placebo
Hide Arm/Group Description Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily Placebo: 7.5 mL by mouth three times daily
All-Cause Mortality
Xylitol Syrup Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Xylitol Syrup Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4/160 (2.50%)   1/166 (0.60%) 
Blood and lymphatic system disorders     
Lymphadenitis  0/160 (0.00%)  1/166 (0.60%) 
Ear and labyrinth disorders     
Tympanostomy tube insertion and adenoidectomy  1/160 (0.63%)  0/166 (0.00%) 
Gastrointestinal disorders     
Gastroenteritis  1/160 (0.63%)  0/166 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia  1/160 (0.63%)  0/166 (0.00%) 
Skin and subcutaneous tissue disorders     
Abscess  1/160 (0.63%)  0/166 (0.00%) 
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Xylitol Syrup Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   89/160 (55.63%)   93/166 (56.02%) 
Gastrointestinal disorders     
Diarrhea  80/160 (50.00%)  84/166 (50.60%) 
Flatulence  32/160 (20.00%)  35/166 (21.08%) 
Abdominal Pain  15/160 (9.38%)  8/166 (4.82%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection  63/160 (39.38%)  58/166 (34.94%) 
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Louis Vernacchio, MD, MSc
Organization: Boston Children's Hospital
Phone: 617-919-4283
EMail: louis.vernacchio@childrens.harvard.edu
Layout table for additonal information
Responsible Party: Louis Vernacchio, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT01044030     History of Changes
Other Study ID Numbers: 09-09-0455
RC1DC010668-01 ( U.S. NIH Grant/Contract )
First Submitted: January 6, 2010
First Posted: January 7, 2010
Results First Submitted: March 10, 2015
Results First Posted: March 20, 2015
Last Update Posted: June 20, 2018