IP Library Granted Patent US 10,857,189
Granted Patent B2
US 10,857,189 · App. 16/075,073 · Granted Dec 8, 2020

Compositions and methods for preventing and/or treating vitamin B12 deficiency

Inventor: Willem Meindert De Vos (Ede, NL)
Assignee: Caelus Pharmaceuticals B.V.
A61K35/74A61K9/19A61K9/2081A61K47/02A61P1/14A61P1/18A61P3/04A61P31/18
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Quick Facts
Patent No.
US 10,857,189
App. No.
16/075,073
Granted
Dec 8, 2020
Kind
B2
Abstract

A method for preventing and/or treating vitamin B12 deficiency is taught. The method comprises administering a composition comprising pseudovitamin B12-producing bacteria, optionally in conjunction with mucin-degrading and/or propionate-producing bacteria, to a subject in need thereof. The method is particularly suitable for administration to subjects suffering from vitamin B12 deficiency due to metformin treatment for type-2 diabetes, and to subjects having undergone bariatric surgery.

Claims (35)

1. A method of treating vitamin B12 deficiency in a subject, the method comprising:

administering a composition comprising:

an amount of Eubacterium hallii and/or Intestinimonas butyriciproducens effective to increase production of pseudovitamin B12 and/or propionate in the subject's intestine, and

a physiologically acceptable carrier

to the subject so as to treat vitamin B12 deficiency in the subject.

2. The method according to claim 1 , wherein the subject has been diagnosed as having a vitamin B12 deficiency, and the vitamin B12 deficiency is secondary to a condition selected from the group consisting of metformin treatment for type-2 diabetes, pernicious anemia, atrophic gastritis, chronic inflammation of the pancreas, a surgical procedure where part of the stomach and/or small intestine are removed, weight loss (bariatric) surgery, inflammatory bowel disease, Crohn's disease, ulcerative colitis, celiac disease, bacterial infection, heavy drinking, Graves' disease, lupus, long-term use of acid-reducing drugs, malnutrition, bulimia, anorexia nervosa, HIV/AIDS, obesity, high body mass index, pre-diabetes state, insulin resistance, a vegetarian diet, a vegan diet, and any combination thereof.

3. The method according to claim 1 , wherein the composition further comprises:

a propionate-producing bacterium.

4. The method according to claim 3 , wherein the propionate-producing bacterium is present in the composition in an amount ranging from about 10 4 to about 10 15 cells.

5. The method according to claim 3 , wherein the propionate-producing bacterium is Akkermansia muciniphila.

6. The method according to claim 1 , wherein the composition is a pharmaceutical or supplement composition in a form selected from the group consisting of a capsule, tablet, and powder.

7. The method according to claim 1 , wherein the I. butyriciproducens and/or E. hallii and, optionally, a propionate-producing bacterium, is present in lyophilized or microencapsulated form in the composition.

8. The method according to claim 1 , wherein I. butyriciproducens and/or E. hallii is present in the composition in an amount ranging from about 10 4 to about 10 15 cells.

9. The method according to claim 1 , wherein the composition further comprises:

a mucosal binding agent.

10. The method according to claim 1 , wherein the composition further comprises:

a cobalt source selected from the group consisting of cobalt ions, a cobalt salt, cobalt chloride, cobalt sulphate, cobalt acetate, cobalt nitrate, and any combination thereof.

11. The method according to claim 1 , wherein the method treats vitamin B12 deficiency in a subject.

12. A method of treating a subject to increase production of pseudovitamin B12 and/or propionate in the subject's intestine, the method comprising:

administering a composition comprising:

an amount of Intestinimonas butyriciproducens and/or Eubacterium hallii effective to increase production of pseudovitamin B12 and/or propionate in the subject's intestine, and

a physiologically acceptable carrier

to the subject so as to increase the production of pseudovitamin B12 and/or propionate in the subject's intestine so as to treat the subject.

13. The method according to claim 12 , wherein the subject has been diagnosed as having a vitamin B12 deficiency.

14. The method according to claim 13 , wherein the subject has a vitamin B12 deficiency secondary to a condition selected from the group consisting of metformin treatment for type-2 diabetes, pernicious anemia, atrophic gastritis, chronic inflammation of the pancreas, a surgical procedure where part of the stomach and/or small intestine are removed, weight loss surgery, inflammatory bowel disease, Crohn's disease, ulcerative colitis, celiac disease, bacterial infection, heavy drinking, Graves' disease, lupus, long-term use of acid-reducing drugs, malnutrition, bulimia, anorexia nervosa, HIV/AIDS, obesity, high body mass index, pre-diabetes state, insulin resistance, a vegetarian diet, a vegan diet, and any combination thereof.

15. The method according to claim 12 , wherein the composition consists of I. butyriciproducens and a physiologically acceptable carrier.

16. A method of treating vitamin B12 deficiency in a subject, the method comprising:

administering to the subject an amount of Eubacterium hallii and/or Intestinimonas butyriciproducens effective to produce pseudovitamin B12 and/or propionate in the subject's intestine, so as to treat and/or prevent vitamin B12 deficiency in the subject.

17. The method according to claim 16 , wherein the subject has a vitamin B12 deficiency secondary to a condition selected from the group consisting of metformin treatment for type-2 diabetes, pernicious anemia, atrophic gastritis, chronic inflammation of the pancreas, a surgical procedure where part of the stomach and/or small intestine are removed, weight loss surgery, inflammatory bowel disease, Crohn's disease, ulcerative colitis, celiac disease, bacterial infection, heavy drinking, Graves' disease, lupus, long-term use of acid-reducing drugs, malnutrition, bulimia, anorexia nervosa, HIV/AID S, obesity, high body mass index, pre-diabetes state, insulin resistance, a vegetarian diet, a vegan diet, and any combination thereof.

18. The method according to claim 16 , wherein the method treats vitamin B12 deficiency in a subject.

19. A method of treating a subject diagnosed as having a vitamin B12 deficiency to increase production of pseudovitamin B12 and/or propionate in the subject's intestine, the method comprising:

administering to the subject an amount of a composition comprising Eubacterium hallii and/or Intestinimonas butyriciproducens effective to increase the production of pseudovitamin B12 and/or propionate in the subject's intestine,

so as to treat the subject's vitamin B12 deficiency thereby.

20. The method according to claim 19 , wherein the composition consists of I. butyriciproducens and a physiologically acceptable carrier.

21. The method according to claim 19 , wherein the subject has a vitamin B12 deficiency secondary to a condition selected from the group consisting of metformin treatment for type-2 diabetes, pernicious anemia, atrophic gastritis, chronic inflammation of the pancreas, surgical procedure where part of the stomach and/or small intestine are removed, weight loss surgery, inflammatory bowel disease, Crohn's disease, ulcerative colitis, celiac disease, bacterial growth, heavy drinking, Graves' disease, lupus, long-term use of acid-reducing drugs, malnutrition, bulimia, anorexia nervosa, HIV/AIDS, obesity, high body mass index, pre-diabetes state, insulin resistance, a vegetarian diet, a vegan diet, and any combination thereof.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 29, 2025
From: CAELUS PHARMACEUTICALS B.V.
To: CAELUS LIFESCIENCES IP B.V.
Reel/Frame 073329/0457 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 12, 2018
From: DE VOS, WILLEM MEINDERT
To: CAELUS PHARMACEUTICALS B.V.
Reel/Frame 047478/0585 →
Priority Claims (1)
NL 2016323 · Feb 25, 2016 · national
Continuity (1)
Related Publication 20190038678A1 · Feb 7, 2019