Asthma is a chronic disease that typically develops when a person is a child, first as wheezing and wheezing lower respiratory illness and then as a child grows, into asthma, a disease that will follow them throughout their life, as there is currently no cure for asthma.
Asthma is a disruptive disease that requires lifetime management and causes stressors on both children and parents, and it’s no different in New York City, with 10.3% of children living with asthma in 201314 and between 1,874 to 3,713 emergency department visits for children who had an asthma-related illness. It is clear that asthma is affecting the children of New York City at a higher rate than compared to others around the nation at the national rate of 8.6%15.
But the Oral Bacterial Extract (ORBEX) Study aims to change that. The ORBEX Study is a three year study to identify if a daily capsule of Broncho-Vaxom can help prevent or delay young children from developing asthma-like symptoms or wheezing. Broncho-Vaxom is a a capsule of inactive microbes that stimulate the immune system, similar to how a vaccine works, in order to increase the body’s natural defenses against a wide spectrum of respiratory pathogens. It has already been used by 43 million children in countries all over the world.
Participants in the trial will be randomly selected to either take healthy (nonpathogenic) microbes via powder or a placebo via powder (non-active ingredients) for 10 consecutive days each month for two years, and then observed for one year. Modern life has decreased exposure to these naturally occurring microbes, which have resulted in immune systems that are more susceptible to the development of asthma. More information about Broncho-Vaxom can be found on the study page.
Recruitment for the ORBEX Clinical Trial is now closed.
14 New York State Asthma Surveillance Summary Report. (2013, October). Retrieved August 24, 2016, from http://www.health.ny.gov/statistics/ny_asthma/pdf/2013_asthma_surveillance_summary_report.pdf
15 Citizens’ Committee for Children of New York (2013), Keeping Track of New York City’s Children, Tenth Edition
Who Can Participate
The ORBEX Study is limited to participants who meet the following requirements:
- Child is between the ages of 5 - 16 months;
- Must meet at least one of the following criteria; and
- One of the child’s parents has asthma or has been diagnosed with asthma in the past
- Child has been diagnosed with eczema
- Child has a blood sibling, over 4 years of age, with a diagnosis of asthma
- Child has at least one parent/legal guardian who has a working cell phone and can communicate with study staff.
What to Expect?
There will be a total of 12 planned in-clinic visits, a phone call once a month for months when there is not an in-clinic visit scheduled and weekly text messages checking on the health of your child. A full study timeline can be found under the participant timeline section.
To see if your child is eligible to participate in the ORBEX Clinical Trial, please fill out the form.
Principal Investigator
Meyer Kattan, MD
Clinical Site Coordinator
Carmen Liriano
212-305-6265
crl58@cumc.columbia.edu
Location
Morgan Stanley Children’s Hospital
Division of Pediatric Pulmonology
3959 Broadway – CHC 7th Floor
New York, NY 10032
