Method and System for Targeting the Microbiome to Promote Health and Treat Inflammatory Diseases

• US 20170071986A1
• Filed: 11/03/2016
• Published: 03/16/2017
• Est. Priority Date: 02/04/2011
• Status: Active Grant

• Current Assignee: Seed Health, Inc.
• Original Assignee: Joseph E. Kovarik, Katherine Rose Kovarik
• Inventors: Kovarik, Katherine Rose, Kovarik, Joseph E.
• Granted Patent: US 10,010,568 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61C 19/066 Bleaching devices; Whitening agent applicators for teeth, e.g. trays or strips
• CPC Class Codes: A61K 2039/58 raising an immune response against a target which is not the antigen used for immunisation
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/4704 2-Quinolinones, e.g. carbostyril
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 31/546 containing further heterocyclic rings, e.g. cephalothin
• CPC Class Codes: A61K 31/65 Tetracyclines
• CPC Class Codes: A61K 31/7052 having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
• CPC Class Codes: A61K 35/74 Bacteria therapeutic use of a bacterial protein A61K38/00
• CPC Class Codes: A61K 35/741 Probiotics probiotic yeast, e.g. saccharomyces A61K36/06
• CPC Class Codes: A61K 35/742 Spore-forming bacteria, e.g. Bacillus coagulans, Bacillus subtilis, clostridium or Lactobacillus sporogenes
• CPC Class Codes: A61K 35/745 Bifidobacteria
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61K 39/0007 Nervous system antigens; Prions
• CPC Class Codes: A61K 39/0008 Antigens related to auto-immune diseases; Preparations to induce self-tolerance
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/0043 Nose
• CPC Class Codes: A61K 9/006 Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
• CPC Class Codes: A61K 9/007 Pulmonary tract; Aromatherapy

Abstract

A method and system of reducing the likelihood of an inflammatory disease developing by providing a mucosal adhesive strip to a subject, with the strip provided with at least one of a plurality of agents effective to hinder the growth of spirochetes bacteria in a subject'"'"'s oral cavity. In certain embodiments, an effective amount of Prevotella intermedia is provided to decrease the incidence of periodontitis and to reduce the progression of Alzheimer'"'"'s disease. In still other embodiments, the likelihood that a subject will suffer from Alzheimer'"'"'s disease is reduced by administering via local gingival application to a subject that has been diagnosed with periodontitis an effective amount of an antibiotic effective to kill spirochetes bacteria residing on the subgingival tooth area of the subject.

Claims

1. A method of reducing the likelihood of an inflammatory disease developing in a subject, comprising,

providing a bioadhesive strip to a subject that has been diagnosed with periodontitis, wherein said strip has a first and second side, the first side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 1 hour while inside a person'"'"'s mouth, the second side having a specially textured surface that has an anti-microbial characteristic derived from its surface topography, said topography resisting bioadhesion of undesired bacteria that are typically present in a human'"'"'s mouth, said strip being devoid of manganese and copper, said strip having at least one of an antibiotic effective against spirochetes and an anti-biofilm agent.

2. The method as set forth in claim 1, wherein said specially textured surface comprises a pattern defined by a plurality of spaced apart features each having at least one microscale dimension and having at least one neighboring feature having a substantially different geometry.

3. The method as set forth in claim 1, further comprising administering to an oral cavity of the subject an effective amount of Prevotella intermedia, said Prevotella intermedia modified using CRISPR-Cas or CRISPR-Cpf1 to remove at least one virulence factor that lessens the ability of Prevotella intermedia to adhere to surfaces in the oral cavity.

4. The method as set forth in claim 1, wherein said inflammatory disease is Alzheimer'"'"'s disease.

5. The method as set forth in claim 1, further comprising orally administering to the subgingival tooth area of the subject an effective amount of an antibiotic effective to kill spirochetes bacteria residing on the subgingival tooth area of the subject, wherein said antibiotic comprises one of doxycycline, methotrexate, azithromycin and ceftriaxone.

6. The method as set forth in claim 1, wherein said strip is adhered to the subject'"'"'s gingival tissue.

7. The method as set forth in claim 1, wherein said strip includes between 0.2 and 0.9% xylitol by weight.

8. The method as set forth in claim 1, further comprising providing an effective amount of paquinimod to a tooth area of the subject to inhibit collagenase activity.

9. The method as set forth in claim 1, further comprising administering to the subject a pharmaceutically effective amount of a preparation comprising Prevotella intermedia bacteria that produces nitric oxide.

10. The method as set forth in claim 1, wherein said strip comprises bioluminescent material.

11. The method as set forth in claim 1, wherein said strip comprises compounds that facilitate the growth of desired bacteria beneficial to a person'"'"'s health.

12. The method as set forth in claim 1, wherein said strip has at least one surface of said strip having a pattern defined by a plurality of spaced apart features each having at least one microscale dimension and having at least one neighboring feature having a substantially different geometry, wherein an average spacing between adjacent ones of said features is between 0.5 and 5 mu.m.

13. The method as set forth in claim 1, wherein said strip comprises a population of Prevotella bacteria.

14. The method as set forth in claim 1, wherein at least a portion of said strip is dissolvable in a person'"'"'s mouth within a period of 3 hours and wherein said strip has an encapsulated pockets that includes one of Prevotella, iron, NO, antibiotics, anti-inflammatory agents and anti-biofilm agents.

15. The method as set forth in claim 1, further comprising providing, at least 48 hours after said step of administering said antibiotic effective to kill spirochetes bacteria, at least 0.5 mg of a bacterial composition that includes Prevotella bacteria.

16. The method as set forth in claim 1, wherein said strip includes at least about 200 mg. xylitol.

17. The method as set forth in claim 1, an effective amount of an antibiotic effective to kill spirochetes bacteria residing on a subgingival tooth area of the subject, and thereafter further administering to the subject Prevotella intermedia bacteria.

18. A method of reducing the likelihood of an inflammatory disease developing in a subject, comprising,

providing a bioadhesive strip to a subject that has been diagnosed with periodontitis, said strip adapted to bind a mucosal membrane of said subject, the strip having a first and second side, the first side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 1 hour while inside a person'"'"'s mouth, wherein said strip comprises a polymer and between 0.2 and 0.9% xylitol by weight, said strip including a therapeutically effective amount of at least one of an anti-biofilm agent;

an antibiotic comprising one of doxycycline, methotrexate and paquinimod, in an amount effective to inhibit collagenase activity.

19. The method as set forth in claim 18, further comprising orally administering to the subject after at least 24 hours after removal of said strip from the subject, a pharmaceutically effective amount of a preparation comprising Prevotella intermedia bacteria that produces nitric oxide.

20. A method of reducing the likelihood of an inflammatory disease developing in a subject, comprising,

providing a bioadhesive strip to a subject that has been diagnosed with periodontitis, wherein said strip has a first and second side, the first side having a bioadhesive that is adapted to bind to a mucosal membrane for at least 3 hours while inside a person'"'"'s mouth, said strip being devoid of manganese and copper, and including an effective amount of Prevotella intermedia that has been modified to remove at least one virulence factor, wherein said strip includes at least about 200 mg. xylitol and an effective amount of paquinimod to inhibit collagenase activity.