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
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
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)