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US-20260125732-A1 - METHODS OF PREPARING MATERIALS WITH AMMONIA OXIDIZING BACTERIA AND TESTING MATERIALS FOR AMMONIA OXIDIZING BACTERIA

US20260125732A1US 20260125732 A1US20260125732 A1US 20260125732A1US-20260125732-A1

Abstract

This disclosure provides, inter alia, systems and methods for testing products for ammonia oxidizing bacteria, quality control, and providing products with ammonia oxidizing bacteria. The systems and methods herein may be used, inter alia, to treat diseases associated with low nitrite levels, skin diseases, and diseases caused by pathogenic bacteria.

Inventors

  • David R. Whitlock
  • James Heywood
  • Spiros Jamas
  • Larry Weiss

Assignees

  • AOBIOME LLC

Dates

Publication Date
20260507
Application Date
20251230

Claims (20)

  1. 1 . A method of evaluating a preparation for the presence, e.g., level, of ammonia oxidizing bacteria, e.g., a cosmetic product or a therapeutic product, comprising: measuring an amount or a concentration of ammonia oxidizing bacteria in the product to provide a value.
  2. 2 . The method of claim 1 , further comprising classifying the preparation as requiring addition of ammonia oxidizing bacteria or not requiring addition of ammonia oxidizing bacteria.
  3. 3 . The method of any one of claims 1-2 , further comprising comparing the value to a range of values corresponding to a pre-determined range of amounts or concentrations of ammonia oxidizing bacteria.
  4. 4 . The method of claim 3 , further comprising determining if the value is a value in the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria.
  5. 5 . The method of claim 4 , wherein if the value is in the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria, classifying the product as accepted.
  6. 6 . The method of claim 4 , wherein if the value is outside the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria, classifying the product as not accepted.
  7. 7 . The method of any one of claims 4 or 6 , if the value is outside the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria, adding at least one of ammonia oxidizing bacteria, ammonia, ammonium salts, and urea.
  8. 8 . The method of any one of claims 1-7 , further comprising evaluating the product for contaminating organisms.
  9. 9 . The method of any one of claims 1-8 , further comprising evaluating the product for pathogenic organisms.
  10. 10 . The method of claim 9 , wherein the pathogenic organisms are selected from the group consisting of Psuedomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes, Acinetobacter baumannii, Propionibacteria , and Stenotrophomonas , and combinations thereof.
  11. 11 . The method of any one of claims 1-10 , further comprising selecting a sample from the product and conducting testing on the sample.
  12. 12 . The method of any one of claims 3-9 , wherein the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria is between about 10 8 CFU/L to about 10 14 CFU/L.
  13. 13 . The method of any one of claims 3-12 , wherein the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria is between about 50 milligrams (mg) and about 1000 mg of ammonia oxidizing bacteria.
  14. 14 . The method of any one of claims 1-13 , wherein the preparation is useful as a treatment or prevention of a skin disorder, a treatment or prevention of a disease or condition associated with low nitrite levels, a treatment or prevention of body odor, a treatment to supply nitric oxide to a subject, or a treatment to inhibit microbial growth.
  15. 15 . The method of any one of claims 1-14 , wherein the ammonia oxidizing bacteria is selected from the group consisting of Nitrosomonas, Nitrosococcus, Nitrosospira, Nitrosocystis, Nitrosolobus, Nitrosovibrio , and combinations thereof.
  16. 16 . The method of any one of claims 1-15 , further comprising evaluating the preparation from a first batch, e.g., a first batch for commercial release.
  17. 17 . The method of claim 16 , further comprising evaluating the preparation from a second batch, e.g., a second batch for commercial release.
  18. 18 . The method of any one of claims 3-17 , further comprising evaluating the preparation from a plurality of batches to determine if each batch within the plurality meets the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria.
  19. 19 . The method of any one of claims 18 , further comprising releasing the plurality of batches.
  20. 20 . The method of any one of claims 19 , wherein the plurality of batches was prepared simultaneously.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 19/211,117, filed May 16, 2025, which is a continuation of U.S. application Ser. No. 18/939,049, filed Nov. 6, 2024, which is a continuation of U.S. application Ser. No. 18/642,760, filed Apr. 22, 2024, which is a continuation of U.S. application Ser. No. 18/376,710, filed Oct. 4, 2023, which is a continuation of U.S. application Ser. No. 18/125,701, filed Mar. 23, 2023, which is a continuation of U.S. application Ser. No. 17/930,285, filed Sep. 7, 2022, which is a continuation of U.S. application Ser. No. 15/313,174, filed Nov. 22, 2016, which is a U.S. national phase application under 35 U.S.C. § 371 of International (PCT) Patent Application Serial No. PCT/US2015/032017, filed May 21, 2015 which, in turn, claims priority to U.S. Provisional Application No. 62/002,028, filed May 22, 2014, the contents of which are hereby incorporated herein by reference in their entireties for all purposes. BACKGROUND Beneficial bacteria can be used to suppress the growth of pathogenic bacteria. Bacteria and other microorganisms are ubiquitous in the environment. The discovery of pathogenic bacteria and the germ theory of disease have had a tremendous effect on health and disease states. Bacteria are a normal part of the environment of all living things. In the gut, these bacteria are not pathogenic under normal conditions, and in fact improve health by rendering the normal intestinal contents less hospitable for disease causing organisms. Disease prevention is accomplished in a number of ways: nutrients are consumed, leaving less for pathogens; conditions are produced, such as pH and oxygen tension, which are not hospitable for pathogens; compounds are produced that are toxic to pathogens; pathogens are consumed as food by these microorganisms; less physical space remains available for pathogens; and specific binding sites are occupied leaving fewer binding sites available for pathogens. The presence of these desirable bacteria is seen as useful in preventing disease states. There is a need in the art for improved beneficial bacteria that can suppress the growth of non-autotrophic bacteria, e.g., pathogenic bacteria. SUMMARY This disclosure provides, inter alia, a method of evaluating a preparation for the presence, e.g., level, of ammonia oxidizing bacteria, e.g., a cosmetic product or a therapeutic product, comprising measuring an amount or a concentration of ammonia oxidizing bacteria in the product to provide a value. In some embodiments, the method may further comprise classifying the preparation as requiring addition of ammonia oxidizing bacteria or not requiring addition of ammonia oxidizing bacteria. The method may further comprise comparing the value to a range of values corresponding to a pre-determined range of amounts or concentrations of ammonia oxidizing bacteria. The method may further comprise determining if the value is a value in the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria. In some embodiments, if the value is in the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria, the product may be classified as accepted. If the value is outside the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria, the product may be classified as not accepted. In some embodiments, if the value is outside the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria, at least one of ammonia oxidizing bacteria, ammonia, ammonium salts, and urea is added. In some embodiments, the method may further comprise evaluating the product for contaminating organisms. The method may further comprise evaluating the product for pathogenic organisms. In some embodiments, the pathogenic organisms are selected from the group consisting of Psuedomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes, Acinetobacter baumannii, Propionibacteria, and Stenotrophomonas, and combinations thereof. In some embodiments, the method may further comprise selecting a sample from the product and conducting testing on the sample. In some embodiments, the range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria may be between about 108 CFU/L to about 1014 CFU/L. The range of values corresponding to the pre-determined range of amounts or concentrations of ammonia oxidizing bacteria may be between about 50 milligrams (mg) and about 1000 mg of ammonia oxidizing bacteria. In some embodiments, the preparation is useful as a treatment or prevention of a skin disorder, a treatment or prevention of a disease or condition associated with low nitrite levels, a treatment or prevention of body odor, a treatment to supply nitric oxide to a subje