MegaSporeBiotic
is comprised of five verified and tested bacillus
strains: bacillus indicus, bacillus subtilis,
bacillus clausii, bacillus coagulans, and bacillus licheniformis. To date, some
of the most researched and widely used true probiotic strains are from the bacillus species. By utilizing a strong
foundation of research and supervision from the pioneering experts in the field
of bacteriotherapy, each strain carried heavy consideration prior to inclusion
of MegaSporeBiotic’s formula.
The
formulation of MegaSporeBiotic has a deliberate ratio for a combined
colony-forming unit (CFU) of 4 Billion. With particular attention to Bacillus licheniformis, it is important
to note that of all five strains B. licheniformis
carries the smallest concentration of bacterial cells - nearly 50 million CFU. With
that said, the presence of B. licheniformis
in MegaSporeBiotic’s formula is deliberate and thoughtfully measured.
Bacillus Licheniformis as
an Organism in Nature
Bacillus licheniformis is a
ubiquitous organism exposed and consumed by humans for millions of years. As one
the most widely used organisms in the industry, it produces a number of
important compounds. One compound, produced both in vitro and in vivo, individuals
are most familiar with is the antibiotic bacitracin.
B. licheniformis produces this antibiotic
in the presence of pathogens and is effective against pathogens like vibrio. It is important to note that bacitracin is a thermostable antibiotic
that is resistant to enzymatic degradation, making it extremely effective in
the gut. This in vivo antibiotic also helps the function of the main bacillus subtilis antibiotic called subtilisin. Additionally, b. licheniformis produces a stable
protease enzyme vital for digesting and assimilating proteins in the body.
B. licheniformis performs
several important functions in the gut alongside the other bacillus strains. In the natural environment, bacillus licheniformis is almost always found in consortium with b. subtilis, b. coagulans, etc. and have evolved to work as a partnership. Our
ancestors consumed a significant amount of b.
Licheniformis together with b.
subtilis, b. coagulans, b. clausii and likely b. indicus as well. Exposure to these species over millions of
years has become a critical function of our digestive and immune systems. For
this reason, MegaSporeBiotic is designed based on both clinical data and the
natural environment. The formulation mocks the natural consortium of these
species found in nature.
Consumption & Safety of Bacillus Licheniformis as a Probiotic
MegaSporeBiotic has been carefully designed jointly
by microbiologists, doctors, and researchers utilizing a significant amount of
precaution and safety with regards to the strains/species used. The formulation
of MegaSporeBiotic utilized the highest standards of scientific rationale to
determine which species to include or exclude. When defining the safety of a
particular species for use as a probiotic, conclusions are based on in vivo,
controlled safety trials where all variables have been documented. This is true
for establishing safety and efficacy. Determination of safety cannot be
scientifically made on or by including a small number of non-controlled case
studies, especially in cases where variables are unaccounted for.
Each reported research study must be carefully
evaluated and examined to determine if the species of concern is the true
causative agent. If so, the outlying factors must be identified. Fortunately,
numerous researchers have reviewed cases resulting in adverse events with the
use of b. licheniformis. After
reviewing these published studies it was determined that in none of the cases
was b.
licheniformis the causative agent. Additionally, all cases were reported having
included individuals who were severely immunocompromised or with trauma. Bacillus licheniformis was never
determined to be the actual cause of infection, rather only documented as
associated as this species is not naturally infective.
With
regards to cases associated with cattle or feed products, they cannot be
translated to human use. Strains used in feed are exclusively different from
the human strain. The reason for the difference is because cattle farms are the
breeding ground for mutated, resistant, infectious bacteria. The probiotic
strains get mixed with pathogenic strains of E. coli, listeria, salmonella, etc. that are found highly
prevalent in these farms where antibiotics are heavily used. Due to the high
antibiotic use, pathogens develop resistance and higher virulence. In turn, these traits can be passed on to the
probiotic strains used. This is notably different than the human nutritional
environment.
The most
comprehensive safety review on bacillus licheniformis
was performed by the Environmental Protection Agency (EPA). It was
concluded that,
“B. licheniformis is not a human
pathogen nor is it toxigenic. It is unlikely to be confused with related
species that are. However, if challenged by large numbers of this
microorganism, compromised individuals or those suffering from trauma may be
infected[1].”
In
response to cases with adverse events, the EPA and other researchers have
reviewed each case of reported illness and have come to the conclusion that b. licheniformis could not be determined
to be the causative agent, in the case or simply present in the patient, because
the strain is widely found in the natural environment. Furthermore, Nithya et
al., with the CSIR-Central Food Technological Research Institute, performed a
controlled, in vivo safety and toxicological study with b. licheniformis and found it, "safe for food industry applications."
Bacillus licheniformis is a Generally
Recognized as Safe (GRAS) organism in the United States by the Food and Drug
Administration (FDA) standard for safety and toxicity of bacterial strains and
has Qualified Presumption of Safety (QPS) designation in the European Union
(EU). To date, there is not a single
case report where b. licheniformis
was determined to be the primary causative agent in an infection and all case
reports of adverse events are in subjects that are severely immunocompromised
and/or had significant trauma.
Sincerely,
The Research Team &
Staff at MegaSporeBiotic™
The philosophy behind MegaSporeBiotic includes scientific evidence, research support, and safety with regards to human consumption. It is our objective to provide the highest quality pharmaceutical probiotic product, while making published research accessible for educated decisions on bacteriotherapy.
Questions? Email us
@ info@gomegaspore.com
[1] United States Environmental Protection Agency. (1997, February).
Bacillus Licheniformis Final Risk Assessment. (2015, July). Retrieved from
http://www.epa.gov/biotech_rule/pubs/fra/fra005.htm
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