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

Acute Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044030
• Other study ID #: 09-09-0455
• Secondary ID: RC1DC010668-01
• Status: Completed
• Phase: Phase 3
• Start date: February 2010
• Est. completion date: June 2012

Study information

• Verified date: May 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

Intervention

Drug:
• Xylitol syrup
7.5 mL (5 grams) by mouth three times daily
• Placebo
7.5 mL by mouth three times daily

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Slone Epidemiology Center at Boston University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Children’s Hospital	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Epub 2006 Nov 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	12 weeks
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	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	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	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	12 weeks