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

Phase 3
Waitlist Available
Led By Louis Vernacchio, MD, MSc
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial

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.

Eligible Conditions
  • Ear Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media
Secondary study objectives
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.
Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae
Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media

Side effects data

From 2012 Phase 3 trial • 326 Patients • NCT01044030
50%
Diarrhea
39%
Upper respiratory tract infection
20%
Flatulence
9%
Abdominal Pain
1%
Pneumonia
1%
Tympanostomy tube insertion and adenoidectomy
1%
Gastroenteritis
1%
Abscess
100%
80%
60%
40%
20%
0%
Study treatment Arm
Xylitol Syrup
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Xylitol syrupExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xylitol
Not yet FDA approved

Find a Location

Who is running the clinical trial?

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
181,971 Total Patients Enrolled
Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,621 Total Patients Enrolled
Louis Vernacchio, MD, MScPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
40 Total Patients Enrolled
~21 spots leftby Dec 2025
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