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

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

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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