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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

326 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xylitol syrup

Group Type EXPERIMENTAL

Xylitol syrup

Intervention Type DRUG

7.5 mL (5 grams) by mouth three times daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

7.5 mL by mouth three times daily

Interventions

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Xylitol syrup

7.5 mL (5 grams) by mouth three times daily

Intervention Type DRUG

Placebo

7.5 mL by mouth three times daily

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No