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Probiotic formulations for the treatment and alleviation of metabolic and oxidative stress, inflammation and neurodegeneration

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  • Publication Date:
    May 28, 2024
  • معلومة اضافية
    • Patent Number:
      11992,510
    • Appl. No:
      16/969759
    • Application Filed:
      February 12, 2019
    • نبذة مختصرة :
      In alternative embodiments, provided are probiotic formulations, including compositions, formulations, products of manufacture and kits comprising them, and methods of using them, for the treatment and alleviation of metabolic and oxidative stress, inflammation and neurodegeneration. In alternative embodiments, probiotic formulations as provided herein comprise or consist of any combination of the three probiotic strains: Lactobacillus fermentum NCIMB 5221, Lactobacillus plantarum NCIMB 8826 and Bifidobacteria longum spp. infantis NCIMB 702255. In alternative embodiments, probiotic formulations as provided herein are combined with a triphala. In alternative embodiments, probiotic formulations as provided herein are used for: the treatment of metabolic conditions such as diabetes and obesity, inflammatory conditions such as IBD, IBS, arthritis; and, neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease. In alternative embodiments, probiotic formulations as provided herein are used for: resisting oxidative stress, reducing inflammation, lowering blood and total glucose levels, lowering triglycerides levels and managing insulin resistance.
    • Inventors:
      PROVIVA PHARMA INC. (Montreal, CA)
    • Assignees:
      Proviva Pharma Inc. (Montreal, CA)
    • Claim:
      1. A method of lowering circulating blood glucose level and total glucose level, lowering triglyceride level, and managing insulin resistance in an individual in need thereof, comprising administering to the individual about one to four dosages of a probiotic formulation comprising a combination of three isolated bacterial strains, wherein the three isolated bacterial strains are Lactobacillus fermentum NCIMB 5221, isolated Lactobacillus plantarum NCIMB 8826, and isolated Bifidobacterium longum NCIMB 702255, wherein the lowering is when compared to a corresponding individual not administered with the formulation.
    • Claim:
      2. The method of claim 1 , wherein the individual has type II diabetes, insulin resistance, hyperglycemia, or hyperglyceridemia.
    • Claim:
      3. The method of claim 1 , wherein a prebiotic composition is also administered to the individual.
    • Claim:
      4. The method of claim 3 , wherein the prebiotic composition is polyherbal comprising equal amounts of Emblica offcinalis, Terminalia chebula and Terminalia belerica.
    • Claim:
      5. The method of claim 1 , wherein the three bacterial strains are live or dead.
    • Claim:
      6. The method of claim 1 , wherein each of the three bacterial strains is present at 1×10 5 CFU/ml to 10 11 CFU/ml of the formulation, or between 10 5 CFU/gm and 3.0×10 11 CFU/gm of the formulation.
    • Claim:
      7. The method of claim 1 , wherein the total of the three bacterial strains present is 3.0×10 9 CFU/ml or 3.0×10 9 CFU/gm of the formulation.
    • Claim:
      8. The method of claim 1 , wherein each of the three bacterial strains is present at 1.0×10 9 CFU/ml.
    • Claim:
      9. The method of claim 1 , wherein the individual is a human or an animal.
    • Claim:
      10. The method of claim 1 , wherein the formulation is in the form of a solution, a suspension, an emulsion, a powder, a lozenge, a pill, a syrup, a tablet, a capsule, a geltab, an aerosol, a suppository, a chewing gum, a capsule or a sachet.
    • Claim:
      11. The method of claim 1 , wherein the formulation is administered in an edible material, a drink, or a foodstuff.
    • Claim:
      12. The method of claim 1 , wherein the formulation is administered in a fluid or solid dairy product, milk or condensed milk, drinkable yogurt, yogurt, fermented beverage, ice cream, cheese, soy milk, vegetable juice, fruit juice, sports drink, dessert, jelly, candy, baby food, health food, dietary supplement, or dietary additive.
    • Claim:
      13. A method of slowing the onset or progression of metabolic stress, oxidative stress, and inflammation in an individual in need thereof, comprising administering to the individual about one to four dosages of a probiotic formulation comprising a combination of three isolated bacterial strains, wherein the three isolated bacterial strains are Lactobacillus fermentum NCIMB 5221, isolated Lactobacillus plantarum NCIMB 8826, and isolated Bifidobacterium longum NCIMB 702255.
    • Claim:
      14. The method of claim 13 , wherein the individual has oxidative stress and/or inflammation.
    • Claim:
      15. The method of claim 13 , wherein a prebiotic composition is also administered to the individual.
    • Claim:
      16. The method of claim 13 , wherein the prebiotic composition is polyherbal comprising equal amounts of Emblica offcinalis, Terminalia chebula and Terminalia belerica.
    • Claim:
      17. The method of claim 13 , wherein the three bacterial strains are live or dead.
    • Claim:
      18. The method of claim 13 , wherein each of the three bacterial strains is present at 1×10 5 CFU/ml to 10 11 CFU/ml of the formulation, or between 10 5 CFU/gm and 3.0×10 11 CFU/gm of the formulation.
    • Claim:
      19. The method of claim 13 , wherein the total of the three bacterial strains present is 3.0×10 9 CFU/ml or 3.0×10 9 CFU/gm of the formulation.
    • Claim:
      20. The method of claim 13 , wherein each of the three bacterial strains is present at about 1.0×10 9 CFU/ml.
    • Claim:
      21. The method of claim 13 , wherein the individual is a human or an animal.
    • Claim:
      22. The method of claim 13 , wherein the formulation is in the form of a solution, a suspension, an emulsion, a powder, a lozenge, a pill, a syrup, a tablet, a capsule, a geltab, an aerosol, a suppository, a chewing gum, a capsule or a sachet.
    • Claim:
      23. The method of claim 13 , wherein the formulation is administered in an edible material, a drink, or a foodstuff.
    • Claim:
      24. The method of claim 13 , wherein the formulation is administered in a fluid or solid dairy product, milk or condensed milk, drinkable yogurt, yogurt, fermented beverage, ice cream, cheese, soy milk, vegetable juice, fruit juice, sports drink, dessert, jelly, candy, baby food, health food, dietary supplement, or dietary additive.
    • Patent References Cited:












    • Other References:
      Xie et al. Diabetes Obes. Metab. 13(4): 289-301, 2011, Abstract. cited by examiner
      Pavan et al. Clin. Diag. Lab. Immunol. 10: 696-701, 2003. cited by examiner
      Peterson et al. J. Alternat. Complement. Med. 23: 607-614, 2017. cited by examiner
      Formulab Chow 5008 & Formulab Chow, Irradiated 5008C33, LabChows, Purina, 1 page, Dec. 11, 2009. cited by examiner
      Westfall, S. et al., “Ferulic Acid Produced by Lactobacillus fermentum NCIBM 5221 Reduces Symptoms of Metabolic Syndrome in Drosophila melanogaster”, Journal of Microbial and Biochemical Technology, 2016, v. 8(4), pp. 272-284. cited by applicant
      Tomaro-Duchesneau, C. et al., “Effect of orally administered L. fermentum NCIMB 5521 on markers of metabolic syndrome: an in vivo analysis using ZDF rats”, Appl Microbiol Biotechnol, 2014, v. 98, pp. 115-126. cited by applicant
      Tomaro-Duchesneau, C. et al., “Probiotic Ferulic Acid Esterase Active Lactobacillus fermentum NCIMB 5221 APA Microcapsules for Oral Delivery: Preparation and In Vitro Characterization”, 2012, Pharmaceuticals, v. 5, pp. 236-248. cited by applicant
      Rathore, S. et al., “Production of potentially probiotic beverages using single and mixed cereal substrates fermented with lactic acid bacteria cultures”, 2012, Food Microbiology, v. 30, pp. 239-244. cited by applicant
      Charteris et al., “Edible table (bio)spread containing potentially probiotic Lactobacillus and Bifidobacterium species, 2002, International Journal of Dairy Technology”, v. 55(1), pp. 44-56. cited by applicant
      Westfall, S. et al., “A novel polyphenolic prebiotic and probiotic formulation have synergistic effects on the gut microbiota influencing Drosophila melanogaster physiology”, Artificial Cells, Nanomedicine, and Biotechnology, Apr. 12, 2018, v. 46, No. S2, pp. S441-S455. cited by applicant
      Westfall, S. et al., “Longevity extension in Drosophila through gut-brain communication”, Scientific Reports, Nature, May 30, 2018, v. 8:8362, pp. 1-15. cited by applicant
      Westfall, S. et al., “A polyphenol-rich prebiotic in combination with a novel probiotic formulation alleviates markers of obesity and diabetes in Drosophila, Journal of Functional Foods”, Sep. 1, 2018, v. 48, pp. 374-386. cited by applicant
      International Search Report, International Application No. PCT/CA2019/000018, dated Jun. 5, 2019. cited by applicant
    • Primary Examiner:
      Devi, S.
    • الرقم المعرف:
      edspgr.11992510