Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness
Public ClinicalTrials.gov record NCT02148796. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of ORal Bacterial EXtract for the Prevention of Wheezing Lower Respiratory Tract Illness (ORBEX)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate if Broncho-Vaxom® given to high risk infants for 10 days, monthly, for two consecutive years can increase time to occurrence of the first episode of wheezing lower respiratory tract illness (WLRI) during a three year observation period off therapy.
Study identification
- NCT ID
- NCT02148796
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 822 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 6 Months to 18 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2017 (Actual)
- Primary completion
- Jan 30, 2026 (Actual)
- Completion
- Jan 30, 2026 (Actual)
- Last update posted
- Jun 2, 2026
2017 – 2026
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| University of California San Francisco, Benioff Children's Hospital | Oakland | California | 94609 | — |
| Children's National Health System | Washington D.C. | District of Columbia | 20037 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| Boston Children's Hospital, Harvard University | Boston | Massachusetts | 02115 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| Columbia University | New York | New York | 10032 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | — |
| Cincinnati Children's Hospital & Medical Center | Cincinnati | Ohio | 45229 | — |
| University of Wisconsin | Madison | Wisconsin | 53792-4108 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02148796, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02148796 live on ClinicalTrials.gov.