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-10675312-B2
Publication Date
2020-06-09
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 a method of treating a metabolic disorder in a subject by administering a composition comprising first, second, and third microbes defined by 16S rRNA sequence identity to Akkermansia muciniphila, Eubacterium hallii, and Clostridium beijerinckii. The first microbe comprises a 16S rRNA sequence comprising at least about 97% sequence identity, or at least about 85% sequence identity, to a 16S rRNA sequence of Akkermansia muciniphila, and the second and third microbes are defined by sequence identity to Eubacterium hallii and Clostridium beijerinckii. The metabolic disorder is selected from Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, obesity, and insulin resistance.
The disclosed scope further includes optional addition of additional microbial taxa selected from defined sets, while maintaining the rRNA sequence identity framework. The composition is associated with microbial growth media and formulation components for therapeutic or metabolic microbiome compositions, including nutrients and trace minerals, vitamins, and buffers or salts. The partial content also indicates broad pharmaceutical formulation and delivery formats including oral or enteric-coated forms, topical forms, and routes such as enema and suppository, and optional inclusion of prebiotics such as inulin.
The patent text further describes microbiome-based treatment and diagnostics for metabolic disorders, including microbiome profiling and algorithm-based scoring for disease status and response prediction. It also describes development concepts for microbial consortia, and mentions microbial processing and stability or synergy concepts, along with formulation and administration routes for delivering therapeutically effective microbial compositions to alter gut microbiota and associated metabolic outcomes.
Claims Coverage
Two independent claims are identified, and both are directed to treating a metabolic disorder by administering specific microbe compositions defined by 16S rRNA sequence identity thresholds to Akkermansia muciniphila, Eubacterium hallii, and Clostridium beijerinckii. The inventive features center on the identity-defined three-microbe composition and its use to treat the selected metabolic disorders.
Identity-defined three-microbe composition for metabolic disorder treatment
Administering a composition comprising a first microbe comprising a 16S rRNA sequence comprising at least about 97% sequence identity, or at least about 85% sequence identity, to a 16S rRNA sequence of Akkermansia muciniphila; a second microbe comprising a 16S rRNA sequence comprising at least about 97% sequence identity, or at least about 85% sequence identity, to a 16S rRNA sequence of Eubacterium hallii; and a third microbe comprising a 16S rRNA sequence comprising at least about 97% sequence identity, or at least about 85% sequence identity, to a 16S rRNA sequence of Clostridium beijerinckii, thereby treating a metabolic disorder selected from the group consisting of Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, obesity, and insulin resistance.
Across the independent claims, the core claim coverage focuses on administering a composition containing three specified microbes whose 16S rRNA sequences meet defined sequence identity thresholds to Akkermansia muciniphila, Eubacterium hallii, and Clostridium beijerinckii, for treating metabolic disorders selected from Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus, obesity, and insulin resistance.
Stated Advantages
Increased weight loss.
Improved glucose tolerance.
Documented Applications
Use of multi-strain consortia including inulin in diet-induced obese mice.
Proposed double-blind placebo controlled randomized study in humans.
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