Food Compositions for Weaning

• US 20190069586A1
• Filed: 03/13/2017
• Published: 03/07/2019
• Est. Priority Date: 03/11/2016
• Status: Active Application

• Current Assignee: Infinant Health, Inc.
• Original Assignee: Evolve Biosystems Inc.
• Inventors: KYLE, David, FREEMAN-SHARKEY, Samara, FRESE, Steven
• Application Number:
  US16/084,207
• Publication Number:
  US 20190069586A1
• Time in Patent Office: Days
• CPC Class Codes: A23K 10/18 of live microorganisms
• CPC Class Codes: A23K 20/163 Sugars; Polysaccharides
• CPC Class Codes: A23K 50/30 for swines
• CPC Class Codes: A23K 50/60 for weanlings
• CPC Class Codes: A23L 11/05 Mashed or comminuted pulses or legumes; Products made therefrom A23L11/30 takes precedence; tofu or soya cheese A23L11/45; soy drinks A23L11/65
• CPC Class Codes: A23L 19/105 Sweet potatoes
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23L 33/21 Addition of substantially indigestible substances, e.g. dietary fibres
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2400/125 Casei
• CPC Class Codes: A23V 2400/173 Reuteri
• CPC Class Codes: A23V 2400/517 Bifidum
• CPC Class Codes: A23V 2400/519 Breve
• CPC Class Codes: A23V 2400/529 Infantis
• CPC Class Codes: A23V 2400/533 Longum
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/702 Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• CPC Class Codes: A61K 35/745 : Bifidobacteria
• CPC Class Codes: A61K 35/747 : Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61P 1/12 : Antidiarrhoeals

Abstract

The inventions described herein relate generally to digestive healthcare, and more particularly, to the feeding of mammals, particularly human infants, who are making a transition from a microbiome with lower diversity to a microbiome with higher diversity. These inventions relate to certain foods comprising a fermentable nutritional component and a probiotic component, where the probiotic component is selected, based on genetic and/or metabolic criteria, to specifically metabolize any Free Sugar Monomers (FSMs) and Free Amino Acids (FAAs) or peptides that accumulate as a result of the fermentable nutritional component in the lower intestine, where they otherwise might be left in the environment to be fermented and metabolized by less adapted/opportunistic bacteria, creating blooms of deleterious intestinal bacteria and shifting the microbiome to a potentially dysbiotic state. The present inventions provide combinations of foods and probiotic bacteria that can protect the mammalian gut from blooms of pathogenic bacteria under the circumstances where the mammalian gut is starting out with a low microbial diversity, such as in weaning infants, or individuals who are post-antibiotic treatment and/or post-chemotherapeutic treatment and transitioning to a higher diversity adapted/stable microbiome.

Claims

1. A composition comprising a non-milk food and a bacterial culture.

2. The composition of claim 1, wherein the bacterial culture comprises commensal bacteria.

3. The composition of claim 1 or 2, wherein the bacterial culture is selected from the species of Lactobacillus, Bifidobacterium, Pediococcus and combinations thereof.

4. The composition of any one of claims 1-3, further comprising mammalian milk oligosaccharides (MMO).

5. The composition of claim 4, wherein the MMO is from a human, bovine, equine, or caprine source.

6. The composition of claim 4 or 5, wherein the MMO comprises HMO, BMO, BCO, GMO, GOS, or combinations thereof.

7. The composition of any one of claims 4-6, wherein the dietary fiber in the composition comprises at least 20% of MMO.

8. The composition of any one of claims 4-7, wherein the dietary fiber in the composition comprises at least 30% of MMO.

9. The composition of any one of claims 4-8, wherein the dietary fiber in the composition comprises at least 40% of MMO.

10. The composition of any one of claims 4-9, wherein the dietary fiber in the composition comprises at least 50% of MMO.

11. The composition of any one of claims 4-10, wherein the dietary fiber in the composition comprises at least 60% of MMO.

12. The composition of any one of claims 4-11, wherein the dietary fiber in the composition comprises at least 70% of MMO.

13. The composition of any one of claims 1-12, wherein less than 10% of the dietary fiber in the composition is provided by the non-milk food.

14. The composition of any one of claims 1-13, wherein the bacterial culture is provided in a dose from 10⁷-10¹² cfu.

15. The composition of any one of claims 1-14, wherein the non-milk food is a feed for a non-human mammal.

16. The composition of claim 15, wherein the non-human mammal is a pig, cow, goat, sheep, horse, dog, or cat.

17. The composition of any one of claims 1-14, wherein the non-milk food is a food for a human.

18. The composition of claim 17, wherein said human is a baby.

19. The composition of any one of claim 17 or 18, wherein the human has a microbiome in need of increasing its complexity by at least 10%.

20. The composition of any one of claims 17-19, wherein the human has a microbiome in need of increasing its complexity by at least 20%.

21. The composition of any one of claims 17-20, wherein the human has a microbiome in need of increasing its complexity by at least 30%.

22. The composition of any one of claims 17-21, wherein the human is receiving or has just completed a course of oral antibiotics.

23. The composition of any one of claims 17-22, wherein the human is receiving or has just completed a course of chemotherapy.

24. The composition of any one of claims 17-23, wherein the human is receiving or has just completed a fecal microbial transplant.

25. The composition of any one of claims 3-24, wherein the Bifidobacteria is selected from B. longum subsp longum, B. longum subsp infantis, B. breve, Bacterium pseudocatanulatum, B. bifidum, B. adolescentis, B. pseudolongum, and B. animalis.

26. The composition of any one of claims 3-25, wherein the Lactobacillus is selected from L. crispatus, L. casei, L. silivarius, L. reuteri, and L. plantarum.

27. The composition of any one of claims 3-26, wherein the Pediococcus is selected from P. pentosaceus, P. stilesii, P. acidilacti, P. argentenicus, and P. claussenii.

28. The composition of any one of claims 1-27, wherein the non-milk food comprises complex oligosaccharides from meat, fish, eggs, shellfish, fruits, vegetables, grains, nuts, seeds, or combinations thereof.

29. The composition of claim 28, wherein the non-milk food comprises complex oligosaccharides from barley, corn, hummus, lentils, oats, rice, wheat, avocado, beetroot, broccoli, squash, carrots, green beans, peas, potatoes, cassava, sweet potatoes, pumpkin, apples, bananas, plantains, blueberries, mango, peach, pear, papaya, watermelon, or combinations thereof.

35. A method of increasing the gut microbiome complexity in a subject in need thereof comprising administering to the subject in need thereof a composition of any one of claims 1-33.

36. The method of claim 35, wherein the subject in need thereof is receiving antibiotic therapy.

37. The method of claim 35, wherein the subject in need thereof has recently finished antibiotic therapy.

38. The method of any one of claims 35-37, wherein the subject in need thereof is receiving or has recently received a fecal microbial transplant.

39. The method of any one of claims 35-38, wherein the subject in need thereof is a human.

40. The method of claim 39, wherein the human is not an infant.

41. The method of any one of claim 39 or 40, wherein the human is an adult.

30. A composition of a non-milk food comprising MMO from a human, bovine or caprine source.

32. The composition of claim 30 or 31, further comprising and a bacterial culture.

33. The composition of claim 32, wherein the bacterial culture comprises bacteria of the genus Bifidobacteria, Lactobacillus, Pediococcus, or combinations thereof.

34. The composition of any one of claims 30-33, wherein the non-milk food is a food for a human baby.

31. A composition of a non-milk food comprising HMO, BMO, BCO, GMO, GOS, or combinations thereof.

42. A method of increasing the gut microbiome complexity in a subject in need thereof comprising administering a non-milk food, MMO, and a bacterial culture to the subject in need thereof.

43. The method of claim 42, wherein the MMO are derived from or substantially identical to human milk glycans, bovine milk glycans, or goat milk glycans.

44. The method of claim 42, wherein the MMO comprises HMO, BMO, BCO, GMO, GOS, or combinations thereof.

45. The method of any one of claims 42-44, wherein the bacterial culture comprises bacteria from Bifidobacteria, Lactobacillus, Pediococcus, or combinations thereof.

46. The method of claim 45, wherein the bacterial culture comprises B. infantis, B. breve, L. plantarium, L. reuteri, or combinations thereof.

47. The method of claim 46, wherein the bacterial culture is provided in a daily dose of from 10⁷-10¹² cfu.

48. The method of any one of claims 42-47, wherein the milk glycans are added to the food such that they represent at least 20% of the total daily dietary fiber of the diet.

49. The method of any one of claims 42-48, wherein the bacterial culture comprises Bifidobacteria longum subsp. infantis.

50. The method of any one of claims 42-49, wherein the subject in need thereof is receiving antibiotic therapy.

51. The method of claim 50, wherein the subject in need thereof has recently finished antibiotic therapy.

52. The method of any one of claims 42-51, wherein the subject in need thereof is receiving or has recently received a fecal microbial transplant.

53. The method of any one of claims 42-52, wherein the subject in need thereof is a human.

54. The method of claim 53, wherein the human is an adult.

55. A method of increasing the gut microbiome complexity in a subject in need thereof comprising administering a fecal microbial transplant composition comprising a fecal microbiome from a healthy individual, milk glycan, and a bacterial culture.

56. The method of claim 55, wherein the fecal microbial transplant composition comprises 5 g of the milk glycan.

57. The method of any one of claim 55 or 56, wherein the bacterial culture comprises bacteria of the genus Bifidobacteria, Lactobacillus, Pediococcus, or combinations thereof.

58. The method of any one of claims 55-57, wherein the bacterial culture comprises Bifidobacterium infantis subsp infantis.

59. The method of any one of claims 56-58, wherein the bacterial culture comprises from 1×

10⁶ to 100×

10⁹ cfu of the bacteria.

60. The method of any one of claims 55-59, wherein the subject in need thereof has been given a controlled diet prior to the fecal microbial transplant.

61. The method of claim 60, wherein the controlled diet comprises low-fiber food and milk glycan

62. The method of claim 61, wherein the controlled diet comprises 1-30 g per day of the milk glycan.

63. The method of any one of claims 60-62, wherein the controlled diet has been administered to said subject for a period of from at least 1 to 7 days prior to the fecal microbial transplant.

64. The method of claim 63, wherein the milk glycan comprises from at least 20% to at least 70% of the total dietary glycans of the controlled diet.

67. The method of claim 61, wherein the bacterial culture comprises B. infantis, B. breve, L. planatrum, L. reuteri, or combinations thereof.

65. A method of increasing the gut microbiome complexity in a human in need thereof comprising administering a composition, wherein the composition comprises weaning food and a bacterial culture, and wherein the composition is in a dry powder form.

66. The method of claim 65, wherein the bacterial culture comprises bacteria from the genus Bifidobacterium, Lactobacillus, or combinations thereof.

68. The method of any one of claim 65 or 66, wherein the bacterial culture further comprises a preservative.

69. The method of any one of claims 65-68, wherein the weaning food comprises meat, fish, eggs, shellfish, fruits, vegetables, grains, nuts, seeds, dairy, or combinations thereof.

70. The composition of claim 69, wherein the weaning food comprises barley, corn, hummus, lentils, oats, rice, wheat, avocado, beetroot, broccoli, squash, carrots, green beans, peas, potatoes, cassava, sweet potatoes, pumpkin, apples, bananas, plantains, blueberries, mango, peach, pear, papaya, watermelon, cheese, or combinations thereof.

71. The method of any one of claims 65-70, wherein the composition comprises bacterial culture and weaning food in a ratio of from 10⁶-10¹¹ cfu of bacterial culture to 100 g of weaning food.