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COMPLETEDPhase 3NCT01044030

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

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 we...

Lead sponsor: Boston Children's Hospital•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Boston Children's Hospital

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Age

0 - 5 years

Sex

ALL

Healthy Volunteers

No

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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 20, 2018Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment326

Start dateFeb 2010

Last updatedJun 20, 2018

Condition

Acute Otitis Media

Locations shown

Children's Hospital Boston

Boston, Massachusetts

Slone Epidemiology Center at Boston University

Boston, Massachusetts

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2018Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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