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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Otitis Media

In brief

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.

Key facts

Study ID

NCT01044030

Run by

Boston Children's Hospital

People needed

326

Starts

2010-02-01

Expected to finish

2012-06-01

Last updated by the study team

2018-06-20

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States
• Slone Epidemiology Center at Boston University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.