IP Library Patent Application 16084154
Patent Application
App. No. 16/084,154

Transient Commensal Microorganism for Improving Gut Health

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Patent No.
US None
App. No.
16/084,154
Abstract

The inventions described herein relate generally to administering compounds to promote mucosal healing in mammals in need thereof including, but not limited to humans. The compounds may include bifidobacteria and mammalian milk oligosaccharides.

Claims (83)

1 . A medicament for treating a patient with intestinal distress comprising a mammalian milk oligosaccharide and a bifidobacteria that internalizes said mammalian milk oligosaccharide prior to its hydrolysis.

2 . The medicament of claim 1 , wherein the intestinal distress represents a microbial dysbiosis.

3 . The medicament of claim 1 , wherein the intestinal distress is the result of Irritable Bowel Disease, Crohn's Disease, Ulcerative colitis, Necrotizing Enterocolitis, bacterial or viral overgrowth, bacterial induced diarrhea, antibiotic treatment, eating disorders, autism, obesity, or low diversity in dietary intake.

4 . The medicament of any one of claims 1 - 3 , wherein the bifidobacteria is selected from B. longum, B. animalis, B. catenulatum, B. pseudolongum, B. pseudocatanulatum , and B. breve.

5 . The medicament of claim 4 , wherein the B. longum is B. longum subs. infantis.

6 . The medicament of any one of claims 1 - 5 , wherein the mammalian milk oligosaccharide is from mammalian milk.

7 . The medicament of claim 6 , wherein the mammalian milk is from human, bovine, or caprine sources.

8 . The medicament of claim 7 , wherein the bovine source is from bovine colostrum.

9 . The medicament of claim 6 , wherein the mammalian milk oligosaccharide is from whey permeate.

10 . The medicament of any one of claims 1 - 9 , wherein the mammalian milk oligosaccharide comprises fucosyllactose, sialyllactose or derivatives thereof.

11 . The medicament of any one of claims 1 - 10 , wherein the mammalian milk oligosaccharide comprises one or more carbohydrates selected from synthetically produced and purified 2′-fucosyllactose, 3-fucosyllactose, difucosyllactose, lacto-N-fucosylpentaose I, lacto-N-fucosylpentaose II, lacto-N-fucosylpentaose III, lacto-N-fucosylpentaose V, 3′-sialyllactose, 6′-sialyllactose, 3′-sialyl-3-fucosyllactose, sialyllacto-N-tetraose, N-acetylgalactosamine, and 6′-sialyllactosamine

12 . The medicament of any one of claims 1 - 11 , wherein the medicament further comprises Lactobacillus and/or Pediococcus.

13 . The medicament of claim 12 , where in the Lactobacillus is selected from L. plantarum, L. antri, L. brevis, L. coleohominis, L. fermentum, L. gasseri, L. johnsonii, L. pentosus, L. sakei, L. sahvarius, L. casei, L. rhamnosus (e.g., LGG), L. acidophilus, L. curvatus, L. reuteri, L. mucosae , and L. crispatus

14 . The medicament of claim 13 , wherein the Lactobacillus is L. reuteri.

15 . The medicament of any one of claims 12 - 14 , wherein the Lactobacillus is provided in a daily dose of from 10 million to 1 trillion cfu.

16 . The medicament of any one of claims 12 - 15 , wherein the Lactobacillus is provided in a daily dose of from 10 billion to 50 billion cfu.

17 . The medicament of any one of claims 1 - 16 , wherein the mammalian milk oligosaccharide is in the form of a powder.

18 . The medicament of any one of claims 1 - 17 , wherein the medicament is in the form of a powder.

19 . The medicament of any of claims 1 - 18 , wherein the oligosaccharide is formulated to provide dietary fiber in an amount suitable for a non-infant patient.

20 . The medicament of claim 19 , wherein the non-infant patient is at least 6 months of age.

21 . The medicament of any one of claims 1 - 20 , wherein the medicament is formulated to provide a daily ration sufficient to support the intestinal microbiome of a patient with a body weight greater than 10 kg.

22 . A method of treating gastrointestinal dysbiosis by providing a patient with a composition comprising a mammalian milk oligosaccharide from a mammalian milk source and bifidobacteria that internalizes said mammalian milk oligosaccharide prior to its hydrolysis for at least 5 days.

23 . The method of claim 22 , wherein the gastrointestinal dysbiosis is associated with Irritable Bowel Disease, Crohn's Disease, Ulcerative colitis, Necrotizing Enterocolitis, bacterial or viral overgrowth, bacterial induced diarrhea, antibiotic treatment, eating disorders, autism, obesity, or low diversity in dietary intake.

24 . The method of any one of claim 22 or 23 , wherein the bifidobacteria is selected from B. longum, B. pseudocatanulatum , and B. breve.

25 . The method of any one of claim 24 , wherein the B. longum is B. longum subs. infantis.

26 . The method of any one of claims 22 - 25 , wherein the mammalian milk oligosaccharide is from a mammalian milk sourced.

27 . The method of any one of claims 22 - 26 , wherein the mammalian milk is from human, bovine, equine, or caprine sources.

28 . The method of claim 27 , wherein the bovine source is from bovine colostrum.

29 . The method of any one of claims 22 - 28 , wherein the mammalian milk oligosaccharide is from whey permeate.

30 . The method of any one of claims 22 - 29 , wherein the mammalian milk oligosaccharide is selected from fucosyllactose, sialyllactose, combinations thereof, and derivatives thereof.

31 . The method of any one of claims 22 - 30 , wherein the mammalian milk oligosaccharide is selected from synthetically produced and purified 2′-fucosyllactose, 3-fucosyllactose, difucosyllactose, lacto-N-fucosylpentaose I, lacto-N-fucosylpentaose II, lacto-N-fucosylpentaose III, lacto-N-fucosylpentaose V, 3′-sialyllactose, 6′-sialyllactose, 3′-sialyl-3-fucosyllactose, sialyllacto-N-tetraose, N-acetylgalactosamine, 6′-sialyllactosamine, and combinations thereof.

32 . The method of claim 22 - 27 , wherein the mammalian milk oligosaccharide is from human sources.

33 . The method of any one of claims 22 - 25 , wherein the mammalian milk oligosaccharide comprises GOS enriched in DP4 and DP5.

34 . The method of any one of claim 22 - 25 or 33 , wherein the mammalian milk oligosaccharide is from a recombinant microorganism.

35 . The method of any one of claim 22 - 25 or 33 , wherein the mammalian milk oligosaccharide is produced by chemical synthesis.

36 . The method of any one of claims 22 - 35 , wherein the bifidobacteria is provided in a daily dose of from 1 million to 100 billion cfu.

37 . The method of any one of claims 22 - 36 , wherein the bifidobacteria is provided in a daily dose of from 10 billion to 50 billion cfu.

38 . The method of any one of claims 22 - 37 , wherein the mammalian milk oligosaccharide is provided in a daily dose of from 1 to 20 g.

39 . The method of any one of claims 22 - 38 , wherein the mammalian milk oligosaccharide is provided in a daily dose of from 1 to 10 g.

40 . The method of any one of claims 22 - 39 , wherein the mammalian milk oligosaccharide and the bifidobacteria are present in a dry form and enrobed in a material that would provide enteric protection.

41 . The method of any one of claims 22 - 39 , wherein the mammalian milk oligosaccharide and the bifidobacteria are encapsulated and the capsule has an enteric coating.

42 . The method of any one of claims 22 - 39 , wherein the mammalian milk oligosaccharide is provided as a solution and the bifidobacteria is provided as an enteric-coated tablet or capsule.

43 . The method of any one of claims 22 - 42 , wherein the composition further comprises Lactobacillus and/or Pediococcus.

44 . The method of claim 43 , wherein the Lactobacillus is selected from L. plantarum, L. casei, L. rhamnosus (e.g., LGG), L. acidophilus, L. curvatus, L. reuteri, L. mucosae , and L. crispatus

45 . The method of claim 44 , wherein the Lactobacillus is L. reuteri.

46 . The method of any one of claims 43 - 45 , wherein the Lactobacillus is provided in a daily dose of from 10 million to 1 trillion cfu.

47 . The method of any one of claims 43 - 46 , wherein the Lactobacillus is provided in a daily dose of from 10 to 50 Billion cfu.

48 . The method of any one of claims 22 - 47 , wherein the mammalian milk oligosaccharide does not include casein.

49 . The method of any one of claims 22 - 48 , wherein the patient is not an infant.

50 . The method of any one of claims 22 - 49 , wherein the patient is on a strict diet restricting all other dietary fiber when said composition is provided to said patient

51 . The method of any one of claims 22 - 50 , wherein the mammalian milk oligosaccharide is in the form of a powder.

52 . The method of any one of claims 22 - 51 , wherein the composition is in the form of a powder.

53 . The method of any of claims 22 - 52 , wherein the oligosaccharide is formulated to provide dietary fiber in an amount suitable for a non-infant patient.

54 . The method of claim 53 , wherein the non-infant patient is at least 6 months of age.

55 . The method of any one of claims 22 - 54 , wherein the composition is formulated to provide a daily ration sufficient to support the intestinal microbiome of a patient with a body weight greater than 10 kg.

56 . A composition comprising human milk oligosaccharides (HMO) and fucosylated glycans (SPF) and/or sialylated glycans (SPS), wherein the SPF and/or SPS are not of milk origin.

57 . The composition of claim 56 , wherein the ratio of HMO:SPF is from 20:1 to 1:5.

58 . The composition of any one of claim 56 or 57 , wherein the composition comprises human milk oligosaccharides and synthetically-produced and purified sialyl glycans (SPS), and wherein the ratio of HMO:SPS is from 5:1 to 1:1.

59 . The composition of any one of claims 56 - 58 , wherein the SPF or SPS comprises one or more of 2′-fucosyllactose, 3′-fucosyllactose, difucosyllactose, lacto-N-fucosylpentose I, lacto-N-fucosylpentose II, lacto-N-fucosylpentose III, lacto-N-fucosylpentose V, 3′-sialyllactose, 6′-sialyllactose, 3′-sialyl-3-fucosyllactose, sialyllacto-N-tetraose, and 6′-sialyllactosamine

60 . The composition of any of claims 56 - 59 , wherein the composition is formulated to provide dietary fiber in an amount suitable for a non-infant patient.

61 . The composition of claim 60 , wherein the non-infant patient is at least 6 months of age.

62 . The composition of any one of claims 56 - 61 , wherein the composition is formulated to provide a daily ration sufficient to support the intestinal microbiome of a patient with a body weight greater than 10 kg.

63 . A composition comprising bovine milk oligosaccharides (BMO) and fucosylated glycans (SPF), wherein the SPF is not of milk origin.

64 . The composition of claim 63 , wherein the ratio of BMO:SPF is from 20:1 to 1:5.

65 . The composition of any one of claim 63 or 64 , wherein the composition comprises bovine milk oligosaccharides and synthetically-produced and purified sialyl glycans (SPS), and wherein the ratio of BMO:SPS is from 5:1 to 1:1.

66 . The composition of any one of claims 63 - 65 , wherein the SPF or SPS comprises of one or more of 2′-fucosyllactose, 3-fucosyllactose, difucosyllactose, lacto-N-fucosylpentaose I, lacto-N-fucosylpentaose II, lacto-N-fucosylpentaose III, lacto-N-fucosylpentaose V, 3′-sialyllactose, 6′-sialyllactose, 3′-sialyl-3-fucosyllactose, sialyllacto-N-tetraose, N-acetylgalactosamine, and 6′-sialyllactosamine.

67 . The composition of any of claims 63 - 66 , wherein the composition is formulated to provide dietary fiber in an amount suitable for a non-infant patient.

68 . The composition of claim 67 , wherein the non-infant patient is at least 6 months of age.

69 . The composition of any one of claims 63 - 68 , wherein the composition is formulated to provide a daily ration sufficient to support the intestinal microbiome of a patient with a body weight greater than 10 kg.

70 . A method of treating gastrointestinal dysbiosis comprising administering a mammalian milk oligosaccharide to a patient in need thereof, wherein the patient in need thereof is a patient with a dysbiotic microbiome.

71 . The method of claim 70 , wherein the dysbiotic microbiome is a bacterial overgrowth of opportunistic pathogens and/or overt pathogens.

72 . The method of claim 70 or 71 , wherein the dysbiotic microbiome has a reduced microbial diversity.

73 . The method of any one of claims 70 - 72 , wherein the mammalian milk is from human, bovine, or caprine sources.

74 . The method of claim 73 , wherein the bovine source is from bovine colostrum.

75 . The method of any one of claims 70 - 74 , wherein the mammalian milk oligosaccharide is from whey permeate.

76 . The method of any one of claims 70 - 75 , wherein the mammalian milk oligosaccharide is selected from fucosyllactose, sialyllactose, combinations thereof, and derivatives thereof.

77 . The method of any one of claims 70 - 76 , wherein the mammalian milk oligosaccharide is selected from synthetically produced and purified 2′-fucosyllactose, 3-fucosyllactose, difucosyllactose, lacto-N-fucosylpentaose I, lacto-N-fucosylpentaose II, lacto-N-fucosylpentaose III, lacto-N-fucosylpentaose V, 3′-sialyllactose, 6′-sialyllactose, 3′-sialyl-3-fucosyllactose, sialyllacto-N-tetraose, N-acetylgalactosamine, 6′-sialyllactosamine, and combinations thereof.

78 . The method of claim 73 , wherein the mammalian milk is from human sources.

79 . The method of any one of claims 70 - 78 , wherein the patient in need thereof is not an infant.

80 . The method of any one of claims 70 - 79 , wherein the mammalian milk oligosaccharide is in the form of a powder.

81 . The method of any of claims 70 - 80 , wherein the mammalian milk oligosaccharide is formulated to provide dietary fiber in an amount suitable for a non-infant patient.

82 . The method of claim 81 , wherein the non-infant patient is at least 6 months of age.

83 . The method of any one of claims 70 - 82 , wherein the mammalian milk oligosaccharide is formulated to provide a daily ration sufficient to support the intestinal microbiome of a patient with a body weight greater than 10 kg.

Assignments (2)
CHANGE OF NAME Recorded Nov 10, 2022
From: EVOLVE BIOSYSTEMS INC.
To: INFINANT HEALTH, INC
Reel/Frame 061914/0408 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 12, 2018
From: KYLE, DAVID; FREEMAN-SHARKEY, SAMARA; FRESE, STEVEN
To: EVOLVE BIOSYSTEMS, INC.
Reel/Frame 046855/0149 →