Synergistic bacterial compositions and methods of production and use thereof
Inventors
Henn, Matthew R. • Litcofsky, Kevin Daniel • D'Onofrio, Anthony Mario • Ohsumi, Toshiro K. • McKenzie, Mary-Jane Lombardo • von Maltzahn, Geoffrey • Cook, David N. • Berry, David Arthur • Afeyan, Noubar B. • Aunins, John Grant
Assignees
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Publication Number
US-11266699-B2
Publication Date
2022-03-08
Expiration Date
Abstract
Provided are therapeutic compositions containing microbial populations for prevention, treatment and reduction of symptoms associated with a dysbiosis of a mammalian subject such as a human.
Core Innovation
The invention relates to a composition comprising at least a first species, a second species, and a third species of isolated bacterium capable of forming a spore, wherein the first species, the second species, and the third species are not identical. The first species comprises Clostridium bolteae, the second species comprises Clostridium orbiscindens, and the third species comprises Blautia producta, with Clostridium orbiscindens comprising a 16S rDNA sequence that is at least 97% identical to SEQ ID NO: 609.
The composition is capable of decreasing and/or inhibiting the growth and/or colonization of Clostridium difficile, as measured by a CivSim assay. The composition further comprises an enteric coating.
The invention also relates to producing the bacterial composition by combining the three non-identical isolated spore-forming bacterial species, with the resulting bacterial composition further comprising an enteric coating and the same CivSim-assay capability to decrease and/or inhibit Clostridium difficile growth and/or colonization.
Claims Coverage
Two independent claims are identified. The claims center on a three-species spore-forming bacterial composition or its production, with defined species membership, a 16S rDNA identity requirement for Clostridium orbiscindens, an enteric coating, and a CivSim assay capability to decrease and/or inhibit Clostridium difficile growth and/or colonization.
Three non-identical spore-forming bacterial species composition
A composition comprising at least a first species, a second species, and a third species of isolated bacterium capable of forming a spore, wherein the first species, the second species, and the third species are not identical.
Defined species members and 16S rDNA identity for Clostridium orbiscindens
The first species comprises Clostridium bolteae, the second species comprises Clostridium orbiscindens, and the third species comprises Blautia producta, wherein Clostridium orbiscindens comprises a 16S rDNA sequence that is at least 97% identical to SEQ ID NO: 609.
CivSim-assay capability to decrease and/or inhibit Clostridium difficile growth and/or colonization
A combination of the first species, the second species, and the third species is capable of decreasing and/or inhibiting the growth and/or colonization of Clostridium difficile, as measured by a CivSim assay.
Enteric coating included in the composition
The composition further comprises an enteric coating.
Producing the composition by combining three spore-forming species
A method of producing a bacterial composition comprising combining at least a first species, a second species, and a third species of isolated bacterium capable of forming a spore, wherein the first species, the second species, and the third species are not identical, and the bacterial composition further comprises an enteric coating.
The claim coverage focuses on a multi-species spore-forming bacterial composition defined by Clostridium bolteae, Clostridium orbiscindens, and Blautia producta, a 16S rDNA identity requirement for Clostridium orbiscindens relative to SEQ ID NO: 609, an enteric coating, and a CivSim assay capability to decrease and/or inhibit Clostridium difficile growth and/or colonization.
Stated Advantages
Decreases and/or inhibits the growth and/or colonization of Clostridium difficile as measured by a CivSim assay.
Formulation includes an enteric coating.
Documented Applications
Therapeutic microbiome compositions for decreasing and/or inhibiting growth and/or colonization of GI pathogens, including Clostridium difficile.
Used in a CivSim assay context to decrease and/or inhibit Clostridium difficile growth and/or colonization.
Post-treatment and administered spore-ecology microbiome results are summarized using OTU ternary combinations with prevalence/engraftment/augmentation percentages in the described ecology context.
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