(ORBEX) 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

Trial Status: 

The Oral Bacterial Extract (ORBEX) Study is a three-year study with the goal of identifying if a daily capsule of Broncho-Vaxom®will help prevent or delay young children from developing wheezing or asthma-like symptoms. Broncho-Vaxom has already been used by 43 million children in countries all over the world.

Why is this study being done? 

This research is being done to find out if Broncho-Vaxom® given to high-risk infants for 10 consecutive days each month over a two year period will prevent or reduce wheezing illnesses in the third year when the child is not taking it. Broncho-Vaxom® has been used safely in other countries all over the world; however, it has not been approved by the U.S. Food and Drug Administration for use in the U.S. Therefore, the use of Broncho-Vaxom® for this study is considered investigational.

Broncho-Vaxom® is a mix of components of different bacteria that are often responsible for respiratory infections. It works like an immunization to stimulate your child’s immune system in order to increase the body’s natural defenses against a wide number of respiratory bacteria that cause children to have respiratory illnesses.

How many people will take part in this study? 

The University of Arizona is one of more than 7 clinical centers in the U.S. doing this study. Approximately 926 children will participate in the study nationwide. About 98 children will be enrolled in Arizona.

The ORBEX Study is limited to participants who meet the following requirements:
• Child is between the ages of 5 - 17 months
• Must meet any one (or more) of the following criteria
• One of the child’s parents has asthma or has been diagnosed with asthma in the past
• One of the child's biological siblings has asthma or has been diagnosed with asthma
• Child has been diagnosed with eczema
• At least one parent/legal guardian who can communicate with the study staff in English or Spanish and has a working cell phone.

Contact ORBEX Study Staff for More Information: 
Call Our Office: 520-626-9543
Call or Text: 520-442-7587

National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH)


Research Area: 
Clinical and Population Research
Disease Type: