Acute Otitis MediaPhase 3NCT01044030

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

A Phase 3 study testing Xylitol syrup in people with Acute Otitis Media, run by Boston Children's Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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… Read more about this study

Who is it for?: Ages 6 months to 5 years
Conditions the study is for: Acute Otitis Media
What is being tested?: Xylitol syrup
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 326 participants
Where: 2 sitesUnited States
Study dates: Feb 2010to Jun 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 5 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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 locations and contacts

2 sites in 1 country.

United States2 sites

Children's Hospital Boston
Boston, Massachusetts, 02115
Slone Epidemiology Center at Boston University
Boston, Massachusetts, 02215

Other trials in United States

About this study

Conditions: Acute Otitis Media
Being tested: Xylitol syrup, Placebo
Keywords: otitis media, ear infection
Medical subject headings: Otitis Media, Otitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Xylitol syrupDrug
7.5 mL (5 grams) by mouth three times daily
PlaceboDrug
7.5 mL by mouth three times daily

Study groups in NCT01044030
Study group	Role	What they receive
Xylitol syrup	Experimental	Not described Receives: Drug: Xylitol syrup
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media
Proportion of subjects who remained free of acute otitis media throughout the study period
Measured: 12 weeks

Secondary outcomes (4)

Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media
Proportion of subjects with no antibiotic use during the study period
Measured: 12 weeks
Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae
Proportion of subjects acquiring colonization with Streptococcus pneumoniae and/or nontypeable Haemophilus influenzae among the subset of patients recruited at the local enrolling sites
Measured: 12 weeks
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.
Proportion of subjects colonized with antibiotic resistant S. pneumonia after treatment
Measured: 12 weeks
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.
Proportion of subjects colonized with antibiotic resistant nontypeable H. influenzae after treatment
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Jun 2012

First posted7 Jan 2010 (estimated)
Study startFeb 2010
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Otitis MediaStudies of the same condition, open and under way.
More trials run by Boston Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01044030
Sponsor's protocol ID: 09-09-0455
Other IDs: RC1DC010668-01
Status last verified: May 2018
First submitted: 6 Jan 2010
Last updated: 20 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Vernacchio L, Vezina RM, Mitchell AA. Tolerability of oral xylitol solution in young children: implications for otitis media prophylaxis. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):89-94. doi: 10.1016/j.ijporl.2006.09.008. Epub 2006 Nov 9.
PubMed 17097152
Vernacchio L, Corwin MJ, Vezina RM, Pelton SI, Feldman HA, Coyne-Beasley T, Mitchell AA. Xylitol syrup for the prevention of acute otitis media. Pediatrics. 2014 Feb;133(2):289-95. doi: 10.1542/peds.2013-2373. Epub 2014 Jan 6.
PubMed 24394686

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Short-term Application of Lactoferrin Ventilation Tubes
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Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media

All Acute Otitis Media trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
ClinicalTrials.gov ID: NCT01044030
Acronym / sponsor ID: 09-09-0455
Conditions: Acute Otitis Media
Keywords: otitis media, ear infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 326 participants (actual)
Lead sponsor: Boston Children's HospitalUniversity, hospital or other
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Study start: Feb 2010
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 7 Jan 2010 (estimated)
Results: Posted 20 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Xylitol syrup	Experimental	Drug: Xylitol syrup
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 6 months to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

History of tympanostomy tubes
Intestinal malabsorption or chronic diarrhea
Diabetes mellitus
Any inborn error of metabolism
Parent/guardian unreachable by telephone

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xylitol syrup7.5 mL (5 grams) by mouth three times daily	Drug	Xylitol syrup
Placebo7.5 mL by mouth three times daily	Drug	Placebo

Primary outcome

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

4 secondary outcomes

Effectiveness of Viscous-adherent Xylitol in Reducing Antibiotic Use in Children With Recurrent Acute Otitis Media
Time frame: 12 weeks
Effect of Viscous-adherent Xylitol on Nasopharyngeal and Oropharyngeal Colonization With Streptococcus Pneumoniae and Nontypeable Haemophilus Influenzae
Time frame: 12 weeks
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
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

Results and safety

Results posted to the registry on 20 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Xylitol Syrup	160	141
Placebo	166	146

Primary outcome: Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media

Time frame: 12 weeks. Number. Unit: percentage of particpants

Measure	Xylitol Syrup n = 160	Placebo n = 166
Value	66.9	63.3

Xylitol Syrup vs Placebo: p = 0.6, Chi-squared

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Xylitol Syrup	4 of 160 (2.5%)	89 of 160 (55.6%)	Not reported
Placebo	1 of 166 (0.6%)	93 of 166 (56%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17097152Vernacchio L, Vezina RM, Mitchell AA. Tolerability of oral xylitol solution in young children: implications for otitis media prophylaxis. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):89-94. doi: 10.1016/j.ijporl.2006.09.008. Epub 2006 Nov 9.
Results publication: PubMed 24394686Vernacchio L, Corwin MJ, Vezina RM, Pelton SI, Feldman HA, Coyne-Beasley T, Mitchell AA. Xylitol syrup for the prevention of acute otitis media. Pediatrics. 2014 Feb;133(2):289-95. doi: 10.1542/peds.2013-2373. Epub 2014 Jan 6.

Related trials for Acute Otitis Media

Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Louis Vernacchio, MD, MSc principal investigator

Boston Children's Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xylitol syrup in people with Acute Otitis Media, run by Boston Children's Hospital at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of Viscous-adherent Xylitol Syrup in Reducing Episodes of Clinically-diagnosed Acute Otitis Media (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01044030, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.