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NCT Number: NCT01044030

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

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.

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Key information

Conditions

Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Hospital Boston, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Xylitol syrup

Drug

7.5 mL (5 grams) by mouth three times daily

Placebo

Drug

7.5 mL by mouth three times daily

Primary outcomes

  1. Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media

    Time frame: 12 weeks

    Proportion of subjects who remained free of acute otitis media throughout the study period

Secondary outcomes

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

    Time frame: 12 weeks

    Proportion of subjects with no antibiotic use during the study period

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

    Time frame: 12 weeks

    Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites

  3. 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.

    Time frame: 12 weeks

    Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment

  4. 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.

    Time frame: 12 weeks

    Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 7, 2010
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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