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

The Oral Bacterial Extract (ORBEX) Study is a three year study to see whether the wheezing and lower respiratory tract illnesses that lead to asthma can be prevented. The goal is to find if a medication that is used in Europe, called Broncho-Vaxom®, can prevent wheezing lower respiratory infections in young children. It may work to stimulate a child’s immune system in order to increase the body’s defenses against germs that cause children to have respiratory illnesses.

Study phase: II

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

The ORBEX Study is limited to participants who meet the following requirements:

  • Child is between the ages of 5 - 17 months.
  •  Must meet at least one of the following two criteria:
    • One of the child’s parents has asthma or has been diagnosed with asthma in the past 
    • Child has been diagnosed with eczema

Additional information:

The study consists of a two year treatment period, followed by one year of observation. We’ll ask you to come in for a total of 12 clinic visits over the three years of the study. We will also ask you to complete telephone calls about once a month and respond to weekly text messages. Eligible participants who complete every scheduled study activity will be paid a total of $1,120.

Primary disease category: Asthma & Lung

Secondary disease categories: Children, Infants & Newborns

Sponsor: NIH

Protocol number: 1U10HL130045

Projected enrollment dates: January 2017 to April 2019

Official study title: Randomized, placebo-controlled, multicenter study to assess the efficacy, safety and tolerability of ORal Bacterial EXtract for th eprevention of wheezing lower respiratory tract illness (ORBEX)