Methods and compositions for treatment of microbiome associated disorders
Inventors
Cutcliffe, Colleen • Eid, John S. • Altman, Tomer • Kolterman, Orville G. • Bullard, James H.
Assignees
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Publication Number
US-12233095-B2
Publication Date
2025-02-25
Expiration Date
Abstract
Disclosed herein are methods and compositions for treatment of a microbiome associated disorder. Further, disclosed herein are methods and compositions for modulating short chain fatty acid production in a subject.
Core Innovation
The invention concerns pharmaceutical compositions and methods that use a microbial composition containing a butyrate-producing microbe to treat hyperalgesia, anxiety, or both. The method includes administering an effective amount of the microbial composition to a subject so that the butyrate-producing microbe increases production of butyrate in the subject. The disclosed microbial compositions are positioned to act through changes in the subject’s gut environment associated with short-chain fatty acids.
The disclosure further relates to microbial consortia concepts, including the synergy and stability of microbial consortia. Microbes are defined and selected in part by high-identity 16S rRNA and/or 23S rRNA sequence similarity to specified microbes, and the microbial composition may include large multi-microbe consortia. Primary fermenters include Akkermansia muciniphila and selected Bifidobacterium species, and secondary fermenters include selected Clostridium species and Eubacterium and Faecalibacterium species.
In addition to butyrate-producing microbes, the disclosure describes inclusion of SCFAs including butyrate, and optional prebiotics such as inulin and related options. The invention also encompasses microbes defined by butyrate-pathway enzymes and supports formulation and delivery approaches directed to gut administration, including enteric-coated oral delivery and lyophilized formulations.
Claims Coverage
The document identifies one independent claim directed to treating hyperalgesia, anxiety, or both by administering a microbial composition with butyrate production in the subject. The dependent coverage adds primary and secondary fermenter selections, optional prebiotics, and formulation or food incorporation options.
Treating hyperalgesia, anxiety, or both by administering a butyrate-producing microbe
Administering an effective amount of a microbial composition comprising a butyrate-producing microbe, wherein the butyrate-producing microbe increases production of butyrate in the subject.
Primary fermenter selection
The primary fermenter is selected from Akkermansia muciniphila, Bifidobacterium adolescentis, Bifidobacterium infantis, Bifidobacterium longum, or any combination thereof.
Secondary fermenter selection
The secondary fermenter is one or more of Clostridium beijerinckii, Clostridium butyricum, Clostridium indolis, Eubacterium hallii, Faecalibacterium prausnitzii, or any combination thereof.
Prebiotic selection
The prebiotic is selected from complex carbohydrates or sugars, resistant dextrins or starch, amino acids or peptides, nutritional compounds, and selected oligosaccharides or fibers, including inulin and related options.
Enteric-coated pill formulation
The microbial composition is formulated as an enteric-coated pill.
Incorporation into specified foods
The food is a bar, frozen food product, yogurt or cheese.
The core claim coverage is a therapeutic method using an administered microbial composition containing a butyrate-producing microbe that increases butyrate production in the subject, with dependent coverage specifying fermenter species sets, optional prebiotics, and particular formulation or food incorporation options.
Stated Advantages
Treating hyperalgesia, anxiety, or both in a subject in need thereof by increasing production of butyrate via an administered microbial composition.
Reduces visceral hyperalgesia.
Modulates TRPV1.
Decreases anxiety-like behavior in an IBS mouse model.
Documented Applications
Treating hyperalgesia, anxiety, or both in a subject in need thereof.
Using a microbial composition with a butyrate-producing microbe in connection with butyrate production in the subject’s gut microbiome, including relevance to the gut-brain axis as discussed in the disclosure.
Use in experimental examples involving IBS mouse models, including outcomes such as visceral hyperalgesia and anxiety-like behavior, and modulation of TRPV1.
Clinical-study concepts for metabolic syndrome and behavioral disorders, together with companion diagnostics concepts referencing machine learning and metabolomics.
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