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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01044030
First Posted: January 7, 2010
Last Update Posted: April 29, 2015
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. Read our disclaimer for details.
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Louis Vernacchio, Children's Hospital Boston
  Purpose
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.

Condition Intervention Phase
Acute Otitis Media Drug: Xylitol syrup Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children

Resource links provided by NLM:


Further study details as provided by Louis Vernacchio, Children's Hospital Boston:

Primary Outcome Measures:
  • Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media [ Time Frame: 12 weeks ]
    Proportion of subjects who remained free of acute otitis media throughout the study period


Secondary Outcome Measures:
  • Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 12 weeks ]

Enrollment: 326
Study Start Date: February 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xylitol syrup Drug: Xylitol syrup
7.5 mL (5 grams) by mouth three times daily
Placebo Comparator: Placebo Drug: Placebo
7.5 mL by mouth three times daily

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01044030


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Slone Epidemiology Center at Boston University
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Boston Children’s Hospital
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Louis Vernacchio, MD, MSc Boston Children’s Hospital
  More Information

Publications:
Responsible Party: Louis Vernacchio, Principal Investigator, Children's Hospital Boston
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: April 29, 2015
Last Verified: April 2015

Keywords provided by Louis Vernacchio, Children's Hospital Boston:
otitis media
ear infection

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases