About the ORBEX Study
The Oral Bacterial Extract (ORBEX) Study is a three year study to identify 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.
Participants in the trial will be randomly selected to either take inactive 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. There will be a total of 12 planned in-clinic visits and a phone call once a month when there is not an in-clinic visit scheduled. 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. This is supported by a recently published article in the New England Journal of Medicine.
The article provides details on a study of the Amish and Hutterite populations, where the Amish and Hutterite populations had “marked differences in the prevalence of asthma despite similar genetic ancestors and lifestyles.2” The conclusion of the study is that the increased exposure to microbes, due to the differences in farming techniques and environments, is the reason the Amish children had a significantly lower rate of asthma (none of the Amish children tested had asthma). The exposure to the microbes provides protection against asthma by engaging and shaping a person’s natural immune response.
2 Stein, M. M., Hrusch, C. L., Gozdz, J., Igartua, C., Pivniouk, V., Murray, S. E., . . . Sperling, A. I. (2016). Innate Immunity and Asthma Risk in Amish and Hutterite Farm Children. New England Journal of Medicine N Engl J Med, 375(5), 411-421. doi:10.1056/nejmoa1508749
The ORBEX Clinical Study has 7 main sites nation-wide. For more information on each site, please click on a location.