METHODS AND COMPOSITIONS RELATING TO ISOLATED AND PURIFIED MICROBES
The present disclosure provides a method for formulating a composition of isolated and purified microbes. The present disclosure provides methods for formulating a composition for administration to a subject in need thereof. The method can comprise obtaining a mixture that is substantially dry and comprises about 10% or less residual moisture. The mixture can comprise a population of isolated and purified microbes and a pharmaceutically acceptable carrier. The population can comprise one or more obligate anaerobes that are oxygen-stable. The methods can further comprise encapsulating said mixture in an enteric-coated capsule for delivery to said subject.
1 - 65 . (canceled)
66 . A composition for administration to a subject in need thereof, comprising:
a population of microbes comprising obligate anaerobic microbes, wherein the obligate anaerobic microbes are from a plurality of microbial species, wherein at least 0.1% of the obligate anaerobic microbes are viable at 4 degrees Celsius or at 25 degrees Celsius for at least 14 days, and
wherein the composition is substantially dry and has a residual moisture of 5% or less.
67 . The composition of claim 66 , wherein at least 1% of the obligate anaerobic microbes are viable microbes or active cells.
68 . The composition of claim 66 , wherein the population is encapsulated and wherein at least 20% of the obligate anaerobic microbes are viable microbes or active cells.
69 . The composition of claim 66 , wherein 5% to 75% of the obligate anaerobic microbes are viable microbes or active cells.
70 . The composition of claim 66 , wherein the composition comprises an amount of at least 10 5 viable cells/g of at least one of the microbial species.
71 . The composition of claim 66 , wherein the composition comprises an amount of at least 10 8 viable cells/g of at least one of the microbial species.
72 . The composition of claim 66 , wherein the composition is a powder.
73 . The composition of claim 66 , wherein the obligate anaerobic microbes are viable in greater than 5 μM oxygen.
74 . The composition of claim 66 , wherein the obligate anaerobic microbes are viable in conditions comprising 20% or greater oxygen, by volume.
75 . The composition of claim 66 , wherein at least one of the plurality of microbial species is capable of growing in conditions having 5 μM or less of dissolved oxygen.
76 . The composition of claim 66 , wherein 90% or more of the obligate anaerobic microbes are non-sporulated.
77 . The composition of claim 66 , wherein the population comprises an isolated and purified microbe with a ribosomal RNA (rRNA) sequence comprising at least about 95% sequence identity to a rRNA sequence from Akkermansia muciniphila.
78 . The composition of claim 66 , wherein the population comprises an isolated and purified microbe with a ribosomal RNA (rRNA) sequence comprising at least about 95% sequence identity to a rRNA sequence from Bifidobacterium infantis.
79 . The composition of claim 66 , wherein the population comprises an isolated and purified microbe with a ribosomal RNA (rRNA) sequence comprising at least about 95% sequence identity to a rRNA sequence from Clostridium beijerinckii.
80 . The composition of claim 66 , wherein the population comprises an isolated and purified microbe with a ribosomal RNA (rRNA) sequence comprising at least about 95% sequence identity to a rRNA sequence from Clostridium butyricum.
81 . The composition of claim 66 , wherein the population comprises an isolated and purified microbe with a ribosomal RNA (rRNA) sequence comprising at least about 95% sequence identity to a rRNA sequence from Eubacterium hallii.
82 . The composition of claim 66 , wherein the population comprises at least one microbe from genus Akkermansia and at least one microbe from a genus selected from the group consisting of: Eubacterium, Clostridium, Bifidobacterium , and Faecalibacterium.
83 . The composition of claim 66 , wherein the population comprises Akkermansia muciniphila and Eubacterium hallii.
84 . The composition of claim 66 , wherein the population comprises Akkermansia muciniphila, Clostridium beijerinckii , and Eubacterium hallii.
85 . The composition of claim 66 , wherein the population comprises Clostridium beijerinckii, Clostridium butyricum , and Bifidobacterium infantis.
86 . The composition of claim 66 , wherein the population comprises Akkermansia muciniphila, Bifidobacterium infantis, Clostridium beijerinckii, Clostridium butyricum , and Eubacterium hallii.
87 . The composition of claim 66 , further comprising a prebiotic.
88 . The composition of claim 87 , wherein the prebiotic comprises inulin.
89 . The composition of claim 66 , wherein the composition is formulated for oral delivery.
90 . The composition of claim 66 , wherein the composition is a tablet or capsule.
91 . The composition of claim 90 , wherein the tablet or capsule further comprises one or more enteric coating(s).
92 . The composition of claim 66 , wherein the composition is a food or dietary supplement.