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

NCT01044030 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 326

Last updated 2018-06-20

Study results available
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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.

Conditions

  • Acute Otitis Media

Interventions

DRUG

Xylitol syrup

7.5 mL (5 grams) by mouth three times daily

DRUG

Placebo

7.5 mL by mouth three times daily

Sponsors & Collaborators

Principal Investigators

  • Louis Vernacchio, MD, MSc · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01044030 on ClinicalTrials.gov