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-11278580-B2
Publication Date
2022-03-22
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 relates to a composition comprising Akkermansia muciniphila that has been cultured in a culture medium comprising substantially a plant-based culture medium. The disclosure includes growth-media formulations with trace minerals, vitamins, salts, and buffers, and links these plant-based and buffered growth-media components to improved microbial growth and peak density.
The disclosure further describes pharmaceutical and nutritional formulation options for therapeutic microbial consortia, including stabilizing agents and products such as lyophilized or freeze-dried materials and spore-containing formulations. The compositions are also described with prebiotic components such as inulin, and with enteric-coated delivery using a pH sensitive polymer for delivery to the ileum and upper colon.
In addition to media and formulation, the disclosure provides example microbial compositions including Akkermansia muciniphila and other microbes such as Faecalibacterium prausnitzii, Bifidobacterium and Clostridium species, and Eubacterium hallii. The disclosure includes illustrative stability and preclinical study descriptions reporting increased weight loss and improved glucose control associated with specific compositions (WB0002 and WB0003), including formulations containing inulin.
Claims Coverage
Independent claim coverage is centered on a composition comprising Akkermansia muciniphila cultured in a culture medium comprising substantially a plant-based culture medium. The provided claims also recite formulation longevity, processing form, dose level, and the inclusion of additional microbes characterized by rRNA sequence identity criteria.
Plant-based culture medium for culturing Akkermansia muciniphila
A composition comprising Akkermansia muciniphila, wherein the Akkermansia muciniphila has been cultured in a culture medium comprising substantially a plant-based culture medium.
Shelf life threshold for the composition
The composition has a shelf life of at least about 1 month.
Temperature-specific shelf life threshold
The composition has a shelf life of at least about 1 month when stored at a temperature of about 20°C, 22°C, or 25°C.
Lyophilized presentation of Akkermansia muciniphila
Akkermansia muciniphila is a lyophilized Akkermansia muciniphila.
Minimum CFU level of cultured Akkermansia muciniphila
The composition comprises at least about 10^6 colony forming units (CFU) of the cultured Akkermansia muciniphila.
Additional microbe defined by rRNA sequence identity to Eubacterium hallii
The composition further includes a microbe with an rRNA sequence with at least about 97% sequence identity to a 16s rRNA sequence of Eubacterium hallii.
Across the provided claim set, the main claimed inventive concept is culturing Akkermansia muciniphila in a culture medium comprising substantially plant-based culture medium, with dependent refinements covering shelf life at least about 1 month, including at about 20°C, 22°C, or 25°C, minimum about 10^6 CFU, lyophilized material, and an additional microbe inclusion criterion based on 16s rRNA sequence identity to Eubacterium hallii.
Stated Advantages
Improved microbial growth and peak density associated with the disclosed growth-media formulations.
Improved buffering/acid buffering associated with the disclosed buffered growth-media components.
Increased weight loss and improved glucose control in the disclosed preclinical study descriptions for compositions including WB0002 and WB0003, including formulations containing inulin.
Documented Applications
Therapeutic microbial consortia in pharmaceutical and nutritional formulation contexts.
Enteric-coated oral delivery to the ileum and upper colon using a pH sensitive polymer.
Preclinical study context described using diet-induced obese mice, with reported outcomes including increased weight loss and improved glucose control for specific compositions (WB0002 and WB0003) including inulin-containing formulations.
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