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Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness

NCT02148796 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 822

Last updated 2026-02-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Broncho-Vaxom (BV)

Active Ingredient: Lyophilised bacterial extract; Chemical Name: OM-85 BV; Strength: 3.5 mg; Excipients: bacterial extract, propyl gallate, sodium glutamate, mannitol, pregelatinised starch, magnesium stearate; Appearance: Blue and white capsule; Dosage Form: 3.5 mg capsule; Manufacturer: OM Pharma, Switzerland (OM stands for Omnia Medicamenta) Storage: Store in the original package

OTHER

Placebo

A placebo capsule will be used that will be indistinguishable from the active study drug.

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Principal Investigators

  • Fernando D Martinez, MD · University of Arizona

  • Wayne J Morgan, MD · University of Arizona

  • Dave T Mauger, PhD · Penn State University, Data Coordinating Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2026-01-30
Completion
2026-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02148796 on ClinicalTrials.gov