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Bio Three - AOR-2

Bio–Three

Disclaimer  

*These statements have not been evaluated by the Food and Drug Administration. Ingredient information is not intended to diagnose, treat, cure, or prevent any disease. 

Material Name(s): Enterococcus faecium T-110, Clostridium butyricum TO-A, Bacillus subtilis TO-A 

A note on nomenclature: 

Synonyms 
Enterococcus faecium  Prior to 1984, enterococci were members of the genus Streptococcus; thus, E. faecalis was known as Streptococcus faecalis.i 
Bacillus subtilis  Strains designated by Gibson (1944) and Smith et al. (1946) as synonyms of Bacillus subtilis include Bacillus mesentericus, Bacillus aterrimus, Bacillus natto, etc.ii 

Bio-Three is a proprietary ingredient from Japanese company TOA, a leader in the development and manufacturer of fermented products. Bio-Three is composed of 3 specific probiotic strains: Enterococcus faecium T-110, Clostridium butyricum TO-A and Bacillus subtilis TO-A.  While these strains are relatively new to the North American market, they have been widely used in hospitals and pharmacies throughout Asia since 1941. These bacterial species act in a symbiotic manner, such that each facilitates the proliferation of the others. Further each strain will yield unique metabolites which aid in physiological functions including metabolism, development and homeostasis of immunity. 

  • Clostridium butyricum – produces large amounts of a short chain fatty acid call butyrate which promotes immune function and tolerance. This means it both increases resistance to infections as well as reduces autoimmunity. Butyrate is also a key fuel for other healthy bacteria and also heals and repairs the gut mucosal lining.  Finally, it can reduce inflammation locally in the GI tract as well as throughout the whole body because it can be absorbed into the bloodstream. There are upwards of 60 human clinical studies published on the safety and efficacy of Clostridium butyricum in both adults and in susceptible populations such as in infants and seniors. 
  • Enterococcus faecalis lowers the pH of the gut to make is more inhospitable to pathogenic bacteria. It also produces anti-bacterial compounds called bacteriocins that can inhibit harmful bacteria.  
  • Finally, Bacillus mesentericus exponentially increases the growth of bifidobacteria which are one of the most critical and beneficial classes of bacteria in the gut

Technical insights:

  • Country of origin: Japan
  • The bacterial strains in this product are isolated from safe sources – E. faecium and C. butyricum are isolated from human microbiome, while B. subtilis is isolated from potato skins. And cultured on various media 
  • Lactose media: from New Zealand and Germany  
  • Potato starch media: lump stalk from Japan  
  • No refrigeration needed, store under room temperature 
  • High resistance against bile acid 
  • Low sensitivity to drugs 
Non-GMO-AOR

Non_GMO

Contains lactose

Casein free

Ingredient Benefits

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Promotes a diverse and competitive microbiome

Gut microbial imbalance (dysbiosis) may lead to dysfunction of host machineries, thereby contributing to pathogenesis and/or progression toward a broad spectrum of diseases. Bio- Three has the unique ability to alter the gut environment and shift the microbiota.

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Reduces susceptibility to infection and overgrowth of diarrhea causing microbes

Two of the strains provide protection against antibiotic-associated or traveler’s diarrhea and Clostridium difficile, anti-inflammatory effects, improvement of the gut barrier, allergy protection and more. Butyrate may also prevent diarrhea through an increased passive absorption of water in the colon and its effects on the gut microflora. Butyrate counteracts acute dehydration and may offers long-term treatment and prevention of traveller’s diarrhea.

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Reduce gut inflammation through healing the lining of the gut

The combination of increased gut microbiota and a production of SCFAs results in a decrease in colonic pH, which can inhibit the ability of pathogenic bacteria to survive and bind to the intestinal wall. Butyrate is an essential fuel for other healthy bacteria and also heals and repairs the gut mucosal lining. Finally, it can reduce inflammation locally in the GI tract as well as throughout the whole body because it can be absorbed into the bloodstream.

Safety information:  

For over five years, evidence was submitted to Health Canada to demonstrate the safety, and efficacy of the strains of probiotics in AOR’s Probiotic-3, in order to obtain a product license (Natural Product Number) for sale in Canada. 

Information required for the licensing of this product in Canada is applicable to the American product:

  1. Evidence of virulence testing and lack of horizontal gene transfer: 

Clinical evidence and long-term use were used to support the safety of this synergistic combination of bacteria in humans, however AOR had to engage the help of 3rd party researchers at the University of Calgary to sequence and provide evidence of the virulence factor of the strains in Probiotic-3. The strain sequence is available in the links below. Bioinformatics was used to analyze the sequence of the three strains to confirm the absence of known pathogenic clostridial toxin genes in the species. Polymerase Chain Reaction (PCR) and Southern Blot analysis were used to detect the presence or absence of DNA isolated from the three strains – test samples were negative for virulence. Toxicity analysis in cell models, showed no toxicity. 

 

  1. Additional Safety Information: 

Safety considerations from the Office of Dietary Supplements on general probiotic use by health care professionals: “Given the large quantities of probiotics consumed around the world, the numbers of opportunistic infections that result from currently marketed probiotics are negligible”. The case reports that have shown potential serious adverse events remain inconclusive as to the role of the probiotics in the adverse reaction.  

 

Probiotic-3 containing Bio-Three, has been licensed in Canada since 2016. AOR monitors its products closely for any adverse events in its consumers, in order to remain compliant with Health Canada’s regulations of natural health products. Since its introduction to the market, AOR has only received 7 adverse reaction returns – these are all related to mild gastrointestinal upset that resolved either with continued use or discontinuation of use.  

Bio Three - AOR

Research on this Ingredient

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T2E 8H9

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