Lactic acid bacteria FK-23

Corporate Customers

Heat-treated probiotic FK-23

FK-23, a heat-treated probiotic material, is useful for maintaining true daily health. FK-23 was born through the research and development, and a number of patents were granted to Nichinichi pharmaceutical Co., Ltd. We established a technique for heat-killing method by which the immunity is enhanced up to approximately three-fold compared to the live bacteria.

FK-23 material (Heat-treated probiotic FK-23 powder)

1. Trait

FK-23 material is powder of heat-killed Enterococcus faecalis FK-23 that is derived from pure cultivation. This food material contains over 4000 billion of the bacterial cells per 1 gram. Any extending agents and additives are not included in this material.

2. Quality Standards

Standard item	Standard value	Test method
Dry weight percentage	≦ 5.0%	Atomospheric heat dry
Heavy metal (Pb)	≦ 20ppm	Colorimetric method with sodium sulfate
General bacteria count	≦ 3000 cells/g	Standard agar plate culture method
Coliform	Negative	BGLB method
Fungi count	≦ 300 cells/g	Petrifilm method

3. Examples of Food Labels

Probiotic, Heat-treated probiotic powder, Heat-treated probiotic, etc

Product Trait

1. About Enterococcus faecalis

Enterococcus faecalis is a regular component of the intestinal flora in healthy young adults. It is known that Enterococcus faecalis is deeply involved in maintaining human health.

2. About FK-23

Enterococcus faecalis FK-23 (hereafter abbreviated to FK-23) was screened at Nichinichi pharmaceutical Co., Ltd. Heat-treating of FK-23 enhances the immune-activating effect up to three-fold compared to the live bacteria.

3. Function of FK-23

FK-23 shows an excellent absorptive property in human body, and works on immune cells in the body. Therefore, various values are expected.

Patent	[1] Immune-activating effect	Improve the function of leukocytes and increase the number of leukocytes
Patent	[2] Anti-tumor effect	Reduce the size of tumor
Patent	[3] Suppression of side effects of anticancer drugs	Suppress the growth of tumor and reduce the side effects of anticancer drugs
Patent	[4] Improvement of hepatitis C	Improve the liver functions
Patent	[5] Anti-pathogenic infection effect	Prevent the pathogenic infectious diseases

4. Feature of FK-23

Contain over 4000 billion of the bacterial cells per 1 gram
Original treating method (Granted patent)
Stable physicochemically
Stable preservation (Quality guarantee for two years)
Light colored powder
100% Enterococcus faecalis (No extending agents and additives)

Figure 1 shows that heat-treating of FK-23 (orange) enhances the immune-activating effect up to three-fold compared to the live bacterium (blue).
Figure 2 shows the comparison of immune-activating effect of various types of heat-treated probiotic. It has been cleared that FK-23 (orange) shows higher immune-activating effect than other lactic acid bacteria (blue: Enterococcus faecium, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus brevis, Bifidobacterium breve, Bifidobacterium adolescentis, Bifidobacterium thermophilum, and Streptococcus salivarius).

5. Safety of FK-23

No abnormality was observed in rec assay using Bacillus subtilis and mutagenicity test (micronucleus assay) in mice.
In the subacute toxicity test using rats at high dose of FK-23 (3000?5500 mg/kg), no abnormality was observed on general conditions, body weight, urine analysis, blood analysis, etc. (for human, usual intake is about 20-50 mg/kg).
In clinical test in human adults (intake of 8.1 g FK-23 per day for 4 weeks), no abnormality was observed on all general analyses such as blood pressure, biochemical test of blood, urine analysis, questionnaire and so on.
Enterococcus faecalis FK-23 is confirmed to be safe probiotic bacteria because of the absence of multidrug resistance genes (VRE; vanC-1, vanC-2, and vanC-3).

6. Application of FK-23 to health foods and the references

Research on FK-23 was published to academic journals, presented to academic societies, and granted patents. FK-23 is able to be utilized for various purposes as health food materials not only for human but also for pets, as described below.

Cancer	Patent No. 3040711, Anti-tumor agent and its manufacturing process Patent No. 3040699, Alleviation agent of toxicity Patent No. 3272023, Therapeutic agent on leukocyte reduction Noumi et al., Medical Journal of Japanese Red Cross Society Wakayama Medical Center (2004) Okutomi et al., Biotherapy, 11, p545 (1997) Okutomi T. et al. British Journal of Cancer 75 p1613 1997. Okutomi T. et al., British Journal of Cancer, 75, p1613 (1997) Noumi et al., Yakugaku zasshi, 116, p323 (1996) Hosono A et al., Biosci Biotech Biochem, 59, p940 (1995)
Immune activation (Aquaculture and stockbreeding)	Yuan et al., China Cattle Science, 36, p23 (2010) Kotani et al., Aquaculture science, 56, p375 (2008) Hasegawa T. et al., Int J immunopharmacol, 18, p103 (1996)
Infectious disease Influenza Hepatitis C	Patent No. 2712000, Therapeutic agent on hepatitis C Patent No. 2969017, Protection agent on infection Kondoh et al., Japanese Society for heat-treated probiotic meeting (2010) Suzuki et al., Int Sci Conference of Probiotics and Prebiotics (2010) Khin May Oo et al., The 20th conference of APASL (2010) Hayashi et al., New Food industry, 48, p12 (2006) Maki et al., Medical Journal of Japanese Red Cross Society Wakayama Medical Center (2004) Okutomi T et al., British Journal of Cancer, 75, p1613 (1997) Satonaka K et al., Microbiology and immunol, 40 p217 (1996) Hasegawa et al., Journal of animal clinical medicine, 3, p11 (1991)
Calming intestinal disorders	Ohhashi et al., Journal of nutritional food, 11 (1998)