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

Boston Children's Hospital logo

Boston Children's Hospital

Status and phase

Completed
Phase 3

Conditions

Acute Otitis Media

Treatments

Drug: Placebo
Drug: Xylitol syrup

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01044030
09-09-0455
RC1DC010668-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

326 patients

Sex

All

Ages

6 months to 5 years old

Volunteers

No 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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

326 participants in 2 patient groups, including a placebo group

Xylitol syrup
Experimental group
Treatment:
Drug: Xylitol syrup
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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