NCT01044030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
25 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 20, 2015

Completed
Last Updated

June 20, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

January 6, 2010

Results QC Date

March 10, 2015

Last Update Submit

May 25, 2018

Conditions

Acute Otitis Media

Keywords

otitis mediaear infection

Outcome Measures

Primary Outcomes (1)

  • 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

    12 weeks

Secondary Outcomes (4)

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

    12 weeks

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

    12 weeks

  • 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.

    12 weeks

  • 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.

    12 weeks

Study Arms (2)

Xylitol syrup

EXPERIMENTAL
Drug: Xylitol syrup

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Xylitol syrupDRUG

7.5 mL (5 grams) by mouth three times daily

Xylitol syrup
PlaceboDRUG

7.5 mL by mouth three times daily

Placebo

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Slone Epidemiology Center at Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (2)

  • 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.

    PMID: 17097152BACKGROUND

  • 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.

    PMID: 24394686RESULT

MeSH Terms

Conditions

Otitis MediaOtitis

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Louis Vernacchio, MD, MSc
Organization
Boston Children's Hospital
louis.vernacchio@childrens.harvard.edu
617-919-4283

Study Officials

  • Louis Vernacchio, MD, MSc

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

February 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 20, 2018

Results First Posted

March 20, 2015

Record last verified: 2018-05

Locations

US(2)