Methods and uses of microbiome compositions, components, or metabolites for treating insulin-associated diseases

A method comprising:

• administering to a subject a composition comprising one or more microbial metabolites, wherein the subject has been diagnosed with or is at high risk of developing an insulin-associated disease, disorder, or condition.

The method of any one of the preceding claims, the insulin-associated disease, disorder, or condition is or comprises diabetes, obesity, cardiovascular disease, non-alcoholic fatty liver disease, Wolfram syndrome, metabolic syndrome, insulin resistance, diabetic ketoacidosis, hyperosmolar hyperglycemic state, gestational diabetes, diabetic dermadromes, diabetic neuropathy, diabetic foot ulcers, maturity onset diabetes of the young, pancreatogenic diabetes, or Polycystic ovary syndrome (PCOS).

The method of any one of the preceding claims, wherein the subject is a mammal.

The method of any one of the preceding claims, wherein the subject is a human.

The method of any one of the preceding claims, wherein one or more microbial components or microbial metabolites are selected from Appendix 1, Appendix 3, or Appendix 4.

The method of any one of the preceding claims, wherein the one or more microbial metabolites is or comprises a bile acid.

The method of any one of the preceding claims, wherein the one or more microbial metabolites is or comprises Tauroursodeoxycholic acid.

The method of any one of the preceding claims, wherein one or more microbial components or microbial metabolites is Butyrylcamitine, Theobromine, p-Hydroxyphenylpyruvic acid, Propionic acid, Picolinic acid, 2-Hydroxy-4methylvaleric acid, N6-Acetylysine, Urocanic acid, N5-Ethylglutamine, Trigonelline, Stachydrine, Ectoine, 5-Hydroxylysine, Arginine (arg), Cholic acid, 2-(4-Hydroxyphenyl) propionic acid, N-Acetyltryptophan, Hydroxyproline, Argininosuccinic acid, Glutamic acid (Glu), Sarcosine, 5-Methoxyindoleacetic acid, Indole-3-lactic acid, Isovalerylalanine, N-Acetylleucine, 1-Methylhistidine, N-Acetylephenylalanine, Proline (Pro), or any combination thereof.

The method of any one of the preceding claims, wherein the composition is administered topically, orally, subcutaneously, intravenously, intramuscularly, intracerebrally, intrathecally, rectally, opthalmically, intravitreally, or suprachoroidally.

The method of any one of the preceding claims, wherein the composition is formulated as a syrup, a liquid, a tablet, a troche, a gummy, a capsule, a powder, a gel, a film, an injection, or an eye drop.

A composition for use in treating an insulin-associated disease, disorder, or condition comprising one or more microbial strains or microbial components.

A composition for use in treating an insulin-associated disease, disorder, or condition comprising one or more microbial metabolites.

A method of screening a microbial strain, comprising:

• contacting the microbial strain to a culture comprising pancreatic cells or pancreatic cell lines that model an insulin-associated disease, disorder, or condition, and
• determining whether the microbial strain altered a feature of the culture, wherein the feature is associated with the insulin-associated disease, disorder, or condition.

A method comprising:

• administering to a subject a composition comprising one or more microbial strains or microbial components.

A method comprising:

• administering to a subject a composition comprising one or more microbial metabolites.

A method of characterizing a microbial strain, comprising:

• adding the microbial strain to a culture comprising one or more pancreatic cells or one or more pancreatic cell lines that model an insulin-associated disease, disorder, or condition, and determining whether the microbial strain affects levels of one or more features of the one or more pancreatic cells or pancreatic cell lines, wherein the one or more features are associated with the insulin-associated disease, disorder, or condition.

A method of manufacturing a pharmaceutical treatment comprising characterizing one or more microbial strains, microbial components, or microbial metabolites comprising the steps of:

• adding the one or more microbial strains to a culture comprising one or more pancreatic cells or one or more pancreatic cell lines that model an insulin-associated disease, disorder, or condition, and
• determining whether the one or more microbial strains affect levels of one or more features of the one or more pancreatic cells or pancreatic cell lines, wherein the one or more features are associated with the insulin-associated disease, disorder, or condition.

A method of manufacturing a pharmaceutical treatment comprising:

• formulating one or more microbial strains or microbial components in a syrup, a liquid, a tablet, a troche, a gummy, a capsule, a powder, a gel, a film, an injection, or an eye drop.

A method of manufacturing a pharmaceutical treatment comprising:

• formulating one or more microbial metabolites in a syrup, a liquid, a tablet, a troche, a gummy, a capsule, a powder, a gel, a film, an injection, or an eye drop.

A method of assessing a microbial strain for the ability to affect one or more features of a culture, comprising:

• adding the microbial strain to the culture comprising one or more pancreatic cells or one or more pancreatic cell lines that model an insulin-associated disease, disorder, or condition, and determining whether the microbial strain affects levels of one or more features of the one or more pancreatic cells or pancreatic cell lines, wherein the one or more features are associated with the insulin-associated disease, disorder, or condition.

A composition for use in treating or preventing an insulin-associated disease, disorder, or condition, comprising one or more microbial strains or microbial components.

A composition for use in treating or preventing an insulin-associated disease, disorder, or condition, comprising one or more microbial metabolites.