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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Louis Vernacchio, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01044030
First received: January 6, 2010
Last updated: January 2, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Children's Hospital Boston:

Primary Outcome Measures:
  • To determine the effectiveness of viscous-adherent xylitol syrup in reducing episodes of clinically-diagnosed acute otitis media [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effectiveness of viscous-adherent xylitol in reducing antibiotic use in children with recurrent acute otitis media [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To determine the effect of viscous-adherent xylitol on nasopharyngeal and oropharyngeal colonization with Streptococcus pneumoniae and nontypeable Haemophilus influenzae [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To compare the 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Children's Hospital Boston
Investigators
Principal Investigator: Louis Vernacchio, MD, MSc Children's Hospital Boston
  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
Study First Received: January 6, 2010
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 23, 2014