Oral Bacteria Extract (ORBEX) Study

Objective

To see if taking an Oral Bacterial Extract (ORBEX) can prevent or reduce wheezing illnesses in young children.

Hypothesis

Broncho-Vaxom® contains no live germs and is a mix of components of different germs that cause respiratory infections. It may work like an immunization to stimulate your child’s immune system in order to increase the body’s natural defenses against a wide number of germs that cause children to have respiratory illnesses.

Eligible Subjects

Children ages 5-17 months who are at risk of developing wheezing or asthma.

Participation Requirements

Participants will take Broncho-Vaxom® or a placebo by mouth once daily for 10 days each month for 2 years, and will have physical exams, blood tests, stool and nasal sample collections. Breathing tests will be performed as the children get older. Parents of these subjects will answer questionnaires about their child’s medical history. Parents will also answer questions about their child’s wheezing illnesses through a weekly check-in report and during telephone calls they receive in between study visits.

Participant Reimbursement

Eligible participants will receive physical exams, study medications, small toys and monetary compensation for each completed study visit.

Primary Investigators

Leonard B. Bacharier, MD, Clinical Director, Division of Allergy, Immunology, and Pulmonary Medicine, Washington University School of Medicine.

Current Status 

Recruiting patients.

More Information 

Contact study coordinators at 314-286-1173 or toll free at 866-841-2273.