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EP-3946394-B1 - METHOD AND COMPOSITION FOR THERAPEUTIC MANAGEMENT OF GLUTEN INTOLERANCE

EP3946394B1EP 3946394 B1EP3946394 B1EP 3946394B1EP-3946394-B1

Inventors

  • MAJEED, MUHAMMED
  • NAGABHUSHANAM, KALYANAM
  • BEEDE, Kirankumar
  • ARUMUGAM, SIVAKUMAR
  • Majeed, Shaheen

Dates

Publication Date
20260506
Application Date
20200331

Claims (15)

  1. A method of reducing gluten content in foods, said method comprising step of bringing into contact foods containing gluten with probiotic bacteria Bacillus coagulans individually or in combination with multi enzyme complex to bring about the effect of reducing gluten content, wherein Bacillus coagulans is of strain Bacillus coagulans MTCC 5856.
  2. The method as in claim 1, where the type of gluten is selected from the group consisting of Gliadin, Hordeins, Avenins, and Secalins.
  3. The method as in claim 1, wherein foods containing gluten is selected from the group consisting of barley, wheat, rye, and oats.
  4. The method as in claim 1, wherein an effective dose of Bacillus coagulans is 2×10 9 colony forming units (cfu).
  5. The method as in claim 1, wherein the multi-enzyme complex comprises of a) α-amylase: not less than 24000 DU/g, b) cellulase: not less than 1100 CU/g, c) lipase: not less than 200 FIP/g, d) lactase: not less than 4000 ALU/g and e) neutral or acid protease: not less than 6000 PC/g.
  6. A method of increasing gluten utilization in a mammal, said method comprising step of administering probiotic bacteria Bacillus coagulans individually and/or in combination with multi-enzyme complex to said mammal to bring about an effect of increased fermentation of gluten, wherein Bacillus coagulans is of strain Bacillus coagulans MTCC 5856, wherein the method does not comprise any method for the treatment of a human or animal body by therapy.
  7. The method as in claim 6, wherein an effective dose of Bacillus coagulans is 2×10 9 colony forming units (cfu).
  8. The method as in claim 6, wherein the multi-enzyme complex comprises of a) α-amylase: not less than 24000 DU/g, b) cellulase: not less than 1100 CU/g, c) lipase: not less than 200 FIP/g, d) lactase: not less than 4000 ALU/g and e) neutral or acid protease: not less than 6000 PC/g.
  9. The method as in claim 6, wherein the mammal is human.
  10. A composition comprising probiotic bacteria Bacillus coagulans individually or in combination with multi-enzyme complex for use in therapeutic management of gluten intolerance and related conditions in a mammal by enhancing gluten utilization, said therapeutic management comprising step of administering the composition comprising probiotic bacteria Bacillus coagulans individually or in combination with multi-enzyme complex to said mammal in need of such therapy to bring about a reduction in symptoms of gluten intolerance, wherein Bacillus coagulans is of strain Bacillus coagulans MTCC 5856.
  11. The composition as in claim 10 for the use according to claim 10, wherein, an effective dose of Bacillus coagulans is 2×10 9 colony forming units (cfu).
  12. The composition as in claim 10 for the use according to claim 10, wherein the multi-enzyme complex comprises of a) α-amylase: not less than 24000 DU/g, b) cellulase: not less than 1100 CU/g, c) lipase: not less than 200 FIP/g, d) lactase: not less than 4000 ALU/g and e) neutral or acid protease: not less than 6000 PC/g.
  13. The composition as in claim 10 for the use according to claim 10, wherein the related conditions of gluten intolerance are selected from the group consisting of autoimmune disorders like celiac disease, dermatitis herpetiformis, gluten ataxia, non-celiac gluten sensitivity (NCGS), gluten ingestion, Gluten malabsorption.
  14. The composition as in claim 10 for the use according to claim 10, wherein the mammal is human.
  15. The composition as in claim 10 for the use according to claim 10, wherein the composition comprising Bacillus coagulans individually or in combination with multi-enzyme complex is formulated with pharmaceutically/ nutraceutically acceptable excipients, adjuvants, bases, diluents, carriers, conditioning agents, bioavailability enhancers, antioxidants and preservatives and administered orally in form of tablets, capsules, syrups, gummies, powders, suspensions, emulsions, chewables, candies or eatables.

Description

BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The invention in general relates to probiotic compositions. More specifically, the present invention relates to a composition comprising Bacillus coagulans individually and/or in combination with multi-enzyme complex for the enhancing utilization of gluten and in the therapeutic management of gluten intolerance. DESCRIPTION OF PRIOR ART Gluten is a protein that originates in cereal grains, such as wheat, rye and barley. Role of gluten in wheat is to improve water absorption capacity, viscosity, elasticity of dough. There are two types in gluten proteins viz. gliadin, which is insoluble in water and the soluble glutenin. The gliadin fraction of wheat has been traditionally considered toxic specifically is people with coeliac disease. Coeliac disease is an autoimmune-mediated intestinal disorder induced by prolamins present in wheat (gliadin), rye (secalin) and barley (hordein), and belongs to the most common food-related disorders in western countries. The disease has a strong genetic component (human leucocyte antigen DQ2 or DQ8) and is characterized by small-intestinal villous atrophy, crypt hyperplasia and a profound immune response in the mucosa. Children with gluten intolerance have lot of effects including failure to thrive in infants, delayed puberty in adolescents, irritability in mood, short stature, and dental enamel defects. Gluten free diet has been reported to be an effective treatment strategy for managing gluten intolerance and related conditions like Celiac disease (Niewinski MM, Advances in Celiac Disease and Gluten-Free Diet, J Am Diet Assoc. 2008;108:661-672). Thus, it is imperative to reduce the gluten content in foods and increase gluten utilization to decrease the toxic effects of gluten. Effective diet control measures for people with coeliac disease is to remove gluten from diet. Several research lines are concentrated in developing novel forms of therapy for coeliac disease. These include detoxification of the disease-driving gluten and gliadin peptides as well as blockage of the gluten-induced inflammatory response. Supplementation of digestive enzymes can be an effective therapy for the degradation of gluten. In another approach gluten detoxification can also be done during food processing by fermentation using probiotics and administering probiotics to enhance gluten utilization by the probiotic bacteria. The use of probiotics for the management of gluten intolerance is already reported in literature. 1. Samsel A, Seneff S, Glyphosate, pathways to modern diseases II: Celiac sprue and gluten intolerance. Interdiscip Toxicol. 2013 6(4):159-84. doi: 10.2478/intox-2013-0026.2. De Angelis M, Rizzello CG, Fasano A, Clemente MG, De Simone C, Silano M, De Vincenzi M, Losito I, Gobbetti M. VSL#3 probiotic preparation has the capacity to hydrolyze gliadin polypeptides responsible for Celiac Sprue. Biochim Biophys Acta. 1762(1):80-93. Epub 2005 Oct 213. Wei G, Tian N, Siezen R, Schuppan D, Helmerhorst EJ (2016) Identification of food-grade subtilisin's as gluten-degrading enzymes to treat celiac disease. Am J Physiol Gastrointest Liver Physiol 311(3): G571-G580. The use of digestive enzymes for the management of gluten intolerance and increase utilisation of gluten is also known (Ido et. al., Combination of Gluten-Digesting Enzymes Improved Symptoms of Non-Celiac Gluten Sensitivity: A Randomized Single-blind, Placebo-controlled Crossover Study, Clin Transl Gastroenterol. 2018 Sep; 9(9): 181. However, it is well known in the scientific art that biological effects of probiotics or products thereof are strain specific and cannot be generalised among genera, species and strains (Probiotics: In Depth/NCCIH, U.S. Department of Health and Human Services, National Institutes of Health). Hence, there exists a need to find a superior probiotic strain with improved gluten utilisation and removal potential. The present invention solves the above problem by disclosing the therapeutic potential of probiotic bacteria Bacillus coagulans MTCC 5856 for the management of gluten intolerance and increased removal of gluten from food stuff. The invention also discloses a synergistic combination comprising probiotic bacteria Bacillus coagulans and multi-enzyme complex for above use. It is the principle object of the invention to disclose the use of probiotic bacteria Bacillus coagulans individually or in combination with multi-enzyme complex for removing gluten content in food. It is another objective of the invention to disclose the use of probiotic bacteria Bacillus coagulans individually or in combination with multi-enzyme complex for the enhancing gluten utilization in mammals. It is yet another objective of the invention to disclose probiotic bacteria Bacillus coagulans individually or in combination with multi-enzyme complex for use in the therapeutic management of gluten intolerance and related conditions in mammals The present invention solves the above me