Methods and compositions relating to microbial treatment and diagnosis of disorders
Inventors
Cutcliffe, Colleen • Eid, John S. • Bullard, James H. • SCHICKLBERGER, Marcus F.
Assignees
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Publication Number
US-11213556-B2
Publication Date
2022-01-04
Expiration Date
Abstract
The present disclosure provides methods, systems, compositions, and kits to address the need for microbiome-related treatment of health conditions and disease. The present disclosure provides for treatment of metabolic conditions using microbial compositions.
Core Innovation
The invention provides an oral dosage form comprising a microbe defined by a 16S rRNA sequence comprising at least 97% sequence identity to a 16S rRNA sequence of Eubacterium hallii, and the oral dosage form includes an enteric coating. The microbe is a net producer of acetate generated by growing a bacterium comprising the specified 16S rRNA sequence identity in a substantially plant-based medium.
The substantially plant-based medium comprises yeast extract, a plant-derived peptone, a plant-derived hydrolysate, or a combination thereof, and does not include any animal-derived components. The disclosure also describes vitamins, trace minerals, salts, buffering, and pH ranges in defined plant-based media, including illustrative plant-based media formulations such as PYGveg and GYT veg.
The formulations are described in multiple delivery formats, including enteric-coated capsules, lyophilized powders, pills/capsules, and topical, rectal, or injection routes. The disclosure further relates to microbiome-based therapeutic and diagnostic approaches for metabolic disorders, including Type 2 diabetes mellitus, obesity, and insulin insensitivity, and to sequencing-based profiling and algorithm-based scoring, including a Complete Biome Test and companion diagnostic concepts.
Claims Coverage
The provided claim content includes one independent claim centered on an enteric-coated oral dosage form with a 16S rRNA-defined Eubacterium hallii microbe and net acetate production in a substantially plant-based medium. Dependent claims further refine the medium, formulation format, delivery region, and biological effect endpoint.
Enteric-coated oral dosage form with 16S rRNA-defined microbe
An oral dosage form comprising a microbe comprising a 16S rRNA sequence comprising at least 97% sequence identity to a 16S rRNA sequence of Eubacterium hallii, and an enteric coating.
Net acetate producer grown in substantially plant-based medium
The microbe is a net producer of acetate generated by growing a bacterium comprising a 16S rRNA sequence comprising at least 97% sequence identity to a 16S rRNA sequence of Eubacterium hallii in a substantially plant-based medium comprising yeast extract, a plant-derived peptone, a plant-derived hydrolysate, or a combination thereof.
The claim coverage centers on an enteric-coated oral dosage form with a 16S rRNA identity-defined Eubacterium hallii microbe that is a net producer of acetate when grown in a substantially plant-based medium. The dependent coverage further specifies plant-based medium restrictions and additions, microbe encapsulation vehicles, gastrointestinal delivery regions, and an endpoint related to altering GLP-1 production.
Stated Advantages
Improved weight loss.
Improved glucose tolerance.
Documented Applications
Use of defined microbial consortia with inulin in preclinical/clinical-style studies for metabolic conditions, including obesity-related outcomes and glucose tolerance improvement.
Oral delivery of the specified acetate-producing microbe via an enteric coating, with described targeted GI delivery to the ileum and/or large intestine in dependent claims.
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