Clinical trial NCT01044030: Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
Official title: Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Media
Keywords: otitis media
ear infection
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2010-01-07
Enrollment: 326
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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).

Primary outcomes:
measure: Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media
timeFrame: 12 weeks
Secondary outcomes:
measure: Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media
timeFrame: 12 weeks
measure: Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Boston
country: United States
facility: Slone Epidemiology Center at Boston University
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Louis Vernacchio, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.ijporl.2006.09.008. Epub 2006 Nov 9.
citation: 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.