Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01044030 · ClinicalTrials.gov registry record · Phase 3
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
A Phase 3 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 326
- Enrollment target
NCT01044030: Completed Phase 3 study, sponsored by Boston Children's Hospital.
NCT01044030 is a Phase 3 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 326 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01044030, a Phase 3 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 326 participants
- Enrollment target
Study 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 recurrent acute otitis media.
Primary Outcome
Proportion of subjects who remained free of acute otitis media throughout the study period
Interventions
- DRUG Placebo
- DRUG Xylitol syrup
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 326 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-06 |
| Phase | Phase 3 |
What the finished NCT01044030 record still lists
NCT01044030 is an interventional study that assigns participants to a tested intervention. The registered 326 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01044030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01044030 about?
NCT01044030 is a clinical study titled "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...
What is the current status of trial NCT01044030?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 326 participants. The study started on 2010-02. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01044030?
The interventions under investigation include: Placebo (DRUG), Xylitol syrup (DRUG).
Who is sponsoring clinical trial NCT01044030?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01044030's enrollment target sits among peer trials
326 1075th of 2000 higher than 925 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06410144 · 326 participants · NA
Chronic Kidney Disease-Education (CKD-EDU)
- NCT06586619 · 326 participants · NA
A Remotely Delivered Tai Chi/Qigong Intervention for Older People Living With HIV
- NCT07040566 · 326 participants · Phase 2
A Trial of Varenicline for E-cigarette Cessation
- NCT07165860 · 326 participants · NA
Clinical Trial to Reduce Perinatal Intimate Partner Violence
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia