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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01044030

Public ClinicalTrials.gov record NCT01044030. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 5, 2026, 11:54 AM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01044030
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boston Children's Hospital
Other
Enrollment
326 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Months to 5 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2010 (Type not available)
Primary completion
Jun 2012 (Actual)
Completion
Jun 2012 (Actual)
Last update posted
Jun 20, 2018

2010 – 2012

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Children's Hospital Boston Boston Massachusetts 02115 —
Slone Epidemiology Center at Boston University Boston Massachusetts 02215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01044030, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 20, 2018 · Synced Nov 5, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01044030 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →