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

Primary Purpose

Acute Otitis Media

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Xylitol syrup

Placebo

About this trial

This is an interventional prevention trial for Acute Otitis Media focused on measuring otitis media, ear infection

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Children's Hospital Boston
Slone Epidemiology Center at Boston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xylitol syrup

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media

Proportion of subjects who remained free of acute otitis media throughout the study period

Secondary Outcome Measures

Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media

Proportion of subjects with no antibiotic use during the study period

Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae

Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites

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.

Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment

Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment

Full Information

NCT ID

NCT01044030

First Posted

January 6, 2010

Last Updated

May 25, 2018

Sponsor

Boston Children's Hospital

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

1. Study Identification

Unique Protocol Identification Number

NCT01044030

Brief Title

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

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Boston Children's Hospital

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Otitis Media

Keywords

otitis media, ear infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

326 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xylitol syrup

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Xylitol syrup

Intervention Description

7.5 mL (5 grams) by mouth three times daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

7.5 mL by mouth three times daily

Primary Outcome Measure Information:

Title

Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media

Description

Proportion of subjects who remained free of acute otitis media throughout the study period

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media

Description

Proportion of subjects with no antibiotic use during the study period

Time Frame

12 weeks

Title

Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae

Description

Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites

Time Frame

12 weeks

Title

Description

Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment

Time Frame

12 weeks

Title

Description

Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis Vernacchio, MD, MSc

Organizational Affiliation

Boston Children's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Slone Epidemiology Center at Boston University

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17097152

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.

Results Reference

background

PubMed Identifier

24394686

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.

Results Reference

result

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

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