ROSEBURIA HOMINIS, EUBACTERIUM ELIGENS, AND COMBINATIONS THEREOF AS BIOTHERAPEUTICS
The disclosure relates to live biotherapeutic products, probiotics, pharmaceutical compositions comprising said probiotics, and methods of using them to treat various human diseases. In some aspects, the disclosure provides such compositions comprising strains of the bacteria Rosburia hominis and Eubacterium eligens and their uses in treating metabolic-related diseases or disorders.
1 . A method for treating a metabolic disorder in a subject in need thereof, the method comprising
administering to the subject a composition comprising:
i) a therapeutically effective amount of an isolated Roseburia hominis ( R. hominis ) bacterial strain;
ii) a therapeutically effective amount of an isolated Eubacterium eligens ( E. eligens ) bacterial strain; and
iii) a pharmaceutically acceptable carrier.
2 . The method of claim 1 , wherein the R. hominis and E. eligens are each viable.
3 . The method of claim 1 , wherein the metabolic disorder is selected from the group consisting of hyperglycemia, type 2 diabetes, and a combination thereof.
4 . The method of claim 1 , wherein the metabolic disorder is not type 1 diabetes.
5 . The method of claim 1 , wherein the subject has presented with a fasting blood glucose level of greater than about 125 mg/dL or greater than about 130 mg/dL.
6 . The method of claim 1 , wherein the subject has presented with a 2-hour value for a 75 gram oral glucose tolerance test of greater than about 140 mg/dL.
7 . The method of claim 1 , wherein the therapeutically effective amount of R. hominis comprises about 1×10 7 to 1×10 12 colony forming units (CFU) of R. hominis.
8 . The method of claim 1 , wherein the therapeutically effective amount of E. eligens comprises about 1×10 7 to 1×10 12 colony forming units (CFU) of E. eligens.
9 . The method of claim 1 , wherein the method comprises administering the composition to the subject once, twice or three times per day over a time period of at least about 1-52 weeks.
10 . The method of claim 1 , wherein the method results in a reduction of the subject's fasting blood glucose level of at least about 5%, 10%, 20%, 30% or 40% of the fasting blood glucose level of the subject prior to the first administration of the composition.
11 . The method of claim 10 , wherein the reduction of the subject's fasting blood glucose level is measured at 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, or 12 months after the first administration of the composition.
12 . The method of claim 1 , wherein the Roseburia hominis bacterial strain has a 16S rRNA sequence that is at least 97% identical to SEQ ID NO: 1, a 16S rRNA sequence that is at least 97% identical to SEQ ID NO:2, a 16S rRNA sequence that is at least 97% identical to SEQ ID NO:3, and/or a 16S rRNA sequence that is at least 97% identical to SEQ ID NO:4.
13 . The method of claim 1 , wherein the Eubacterium eligens bacterial strain has a 16S rRNA sequence that is at least 97% identical to SEQ ID NO: 5, a 16S rRNA sequence that is at least 97% identical to SEQ ID NO: 6, a 16S rRNA sequence that is at least 97% identical to SEQ ID NO:7, a 16S rRNA sequence that is at least 97% identical to SEQ ID NO:8, a 16S rRNA sequence that is at least 97% identical to SEQ ID NO:9, and/or a 16S rRNA sequence that is at least 97% identical to SEQ ID NO:10.
14 .- 17 . (canceled)
18 . The method of claim 1 , wherein the Roseburia hominis bacterial strain has a 16S rRNA sequence that is 100% identical to SEQ ID NO: 1, a 16S rRNA sequence that is 100% identical to SEQ ID NO:2, a 16S rRNA sequence that is 100% identical to SEQ ID NO:3, and/or a 16S rRNA sequence that is 100% identical to SEQ ID NO:4.
19 . The method of claim 1 , wherein the Eubacterium eligens bacterial strain has a 16S rRNA sequence that is 100% identical to SEQ ID NO: 5, a 16S rRNA sequence that is 100% identical to SEQ ID NO: 6, a 16S rRNA sequence that is 100% identical to SEQ ID NO:7, a 16S rRNA sequence that is 100% identical to SEQ ID NO:8, a 16S rRNA sequence that is 100% identical to SEQ ID NO:9, and/or a 16S rRNA sequence that is 100% identical to SEQ ID NO:10.
20 . A method for reducing glucose levels in the blood of a subject in need thereof, the method comprising administering to the subject a composition comprising:
i) a therapeutically effective amount of an isolated Roseburia hominis bacterial strain;
ii) a therapeutically effective amount of an isolated Eubacterium eligens bacterial strain; and
iii) a pharmaceutically acceptable carrier.
21 . The method of claim 20 , wherein the blood of the subject has a glucose level greater than 125 mg/dL prior to administering the composition.
22 . The method of claim 20 , wherein the composition is formulated for oral ingestion.
23 . (canceled)
24 . The method of claim 20 , wherein the composition is formulated as a tablet, capsule, a liquid, or a liquid suspension.
25 . A method for treating a gastrointestinal disorder in a subject in need thereof, the method comprising
administering to the subject a composition comprising:
i) a therapeutically effective amount of an isolated Roseburia hominis bacterial strain;
ii) a therapeutically effective amount of an isolated Eubacterium eligens bacterial strain; and
iii) a pharmaceutically acceptable carrier.