Lactic acid bacteria FK-23

FK-23, a lactic acid bacterial 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.

Lactic acid cocci, Enterococcus faecalis - FK-23
FK-23 material (lactic acid bacterial 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

Lactic acid bacteria, Lactic acid bacterial powder, Heat-treated lactic acid bacteria, 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.

Enterococcus faecalis

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 lactic acid bacteria. 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.

  • 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
Hepatitis C
  • Patent No. 2712000, Therapeutic agent on hepatitis C
  • Patent No. 2969017, Protection agent on infection
  • Kondoh et al., Japanese Society for lactic acid bacteria 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)