Methods and Kits For Administering Probiotics

• US 20080241226A1
• Filed: 03/27/2008
• Published: 10/02/2008
• Est. Priority Date: 03/27/2007
• Status: Abandoned Application

• Current Assignee: The Procter & Gamble Company
• Original Assignee: The Procter & Gamble Company
• Inventors: Chen, Ker-Sang, Freeland, Mary Elaine, Charbonneau, Duane Larry, Ebel, James Patrick, Abeln, Susan L.
• Application Number:
  US12/056,702
• Publication Number:
  US 20080241226A1
• Time in Patent Office: Days
• US Class Current: 424/439
• CPC Class Codes: A23F 3/34 Tea substitutes, e.g. matè; Extracts or infusions thereof
• CPC Class Codes: A23K 10/18 of live microorganisms
• CPC Class Codes: A23K 50/40 for carnivorous animals, e.g. cats or dogs
• CPC Class Codes: A23L 33/105 Plant extracts, their artificial duplicates or their derivatives
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/08 Food product presented as a kit of parts
• CPC Class Codes: A23V 2200/32 having an effect on the health of the digestive tract
• CPC Class Codes: A23V 2200/3204 Probiotics, living bacteria to be ingested for action in the digestive tract
• CPC Class Codes: A23V 2250/21 Plant extracts
• CPC Class Codes: A61K 35/745 Bifidobacteria
• CPC Class Codes: A61K 35/747 Lactobacilli, e.g. L. acidophilus or L. brevis
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/02 Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 11/06 Antiasthmatics
• CPC Class Codes: A61P 13/02 of urine or of the urinary tract, e.g. urine acidifiers
• CPC Class Codes: A61P 13/10 of the bladder
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/04 : Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 25/18 : Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/24 : Antidepressants
• CPC Class Codes: A61P 29/00 : Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/02 : Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 3/04 : Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/02 : Immunomodulators
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14

Abstract

Methods for administering probiotics comprising the steps of: administering a loading dose of a loading probiotic for a loading time period; and administering a dose of a botanical and/or additional materials for the loading time period are disclosed. The methods also include administering a maintenance dose of a maintenance probiotic, and/or a botanical and/or an additional material for a maintenance time period. Also disclosed are kits for use in administering probiotics.

Claims

1. A method of administering a probiotic comprising the steps of:

a. administering a loading dose of a loading probiotic for a loading time period; and

b. administering a dose of a botanical for said loading time period.

2. The method of claim 1 further comprising administering an additional material.

3. The method of claim 1 wherein said loading probiotic comprises lactic acid bacteria selected from the group consisting of Bifidobacterium, Lactobacillus, Streptococcus and combinations thereof.

4. The method of claim 3 wherein said lactic acid bacteria comprises an isolated strain of Bifidobacterium infantis.

5. The method of claim 1 wherein said loading probiotic is administered to provide from about 1×

10³ to about 1×

10¹⁴ cfu of loading probiotic per day.

6. The method of claim 1 wherein said loading probiotic is administered to provide from about 1×

10⁵ to about 1×

10¹⁴ cfu of loading probiotic per day.

7. The method of claim 1 wherein said loading probiotic is administered to provide from about 1×

10⁹ to about 1×

10¹² cfu of loading probiotic per day.

8. The method of claim 1 wherein said probiotic is administered in a dosage form selected from the group consisting of:

capsule, chewable tablet, swallowable tablet, buccal tablet, troche, powder, lozenge, soft chew, solution, suspension, spray, tincture, decoction, infusion, syrup, elixir, wafer, food product, and combinations thereof.

9. The method of claim 8 wherein said food product is selected from the group consisting of acidified milk, yogurt, milk powder, tea, juice, beverage, confection, chewable bar, cookie, wafer, cracker, cereal, soft chew, and combinations thereof.

10. The method of claim 1 wherein said botanical exerts benefits on the gastrointestinal system, selected from the group consisting of:

soothing effects, demulcent effects, gas reducing effects, carminative effects, anti-diarrheal effects, astringent effects, laxative effects, aperient effects, cathartic effects, purgative effects, hydrogogue effects, analgesic effects, antispasmodic effects, relaxation effects, stimulant effects, bitter effects, digestive aid effects, health effects, and combinations thereof.

11. The method of claim 1 wherein said botanical is selected from the ginger Family, Licorice root, Marshmallow root, Chamomile, Fennel oil, Fennel Seed, Caraway oil, Caraway seed, Lemon Balm, Horehound Herb, Flaxseed, Flaxseed alpha-linoleic acid, Rosemary Leaf, Rosemary extract, Polyphenols, Avocado extract, Mannoheptulose, and combinations thereof.

12. The method of claim 1 wherein said botanical is provided in a form selected from the group consisting of an extract, tincture, oil, fresh root or rhizome, dried root or rhizome, powdered root or rhizome, whole root or rhizome, infusion, decoction, crystallized matter and combinations thereof.

13. The method of claim 1 wherein said dose of said botanical for said loading time period comprises from about 0.001 g to about 100 grams of said botanical per day.

14. The method of claim 1 wherein said botanical is administered in a dosage form selected from the group consisting of:

capsule, chewable tablet, swallowable tablet, coated tablet, buccal tablet, powder, lozenge, soft chew, solution, suspension, spray, extract, tincture, oil, decoction, infusion, syrup, elixir, food product, and combinations thereof.

15. The method of claim 14 wherein said food product is selected from the group consisting of:

acidified milk, yogurt, milk powder, tea, juice, beverage, confection, chewable bar, cookie, wafer, cracker, cereal, soft chew, treat, and combinations thereof.

16. The method of claim 1 wherein said loading probiotic and said botanical are administered together in a dosage form.

17. The method of claim 2 wherein said additional material is selected from the group consisting of vitamins, minerals, metals, elements, essential fatty acids, essential amino acids, sensates, prebiotics, carotenoids, and combinations thereof.

18. The method of claim 2 wherein said additional material is administered in an amount of from about 0.001 μ

g to about 10 g of said additional material, per day.

19. The method of claim 1 further comprising using a compliance aid to track, assess and improve a user'"'"'s use of and compliance with said method.

20. The method of claim 1 wherein said loading time period comprises from about 1 day to about 60 days.

21. The method of claim 1 further comprising administering a maintenance dose of a maintenance probiotic for a maintenance time period.

22. The method of claim 21 wherein said maintenance dose of said maintenance probiotic during said maintenance time period is an amount effective to maintain alleviation of symptoms.

23. The method of claim 21 wherein said maintenance probiotic comprises lactic acid bacteria selected from the group consisting of Bifidobacterium, Lactobacillus, Streptococcus and combinations thereof.

24. The method of claim 23 wherein said lactic acid bacteria comprises an isolated strain of Bifidobacterium infantis.

25. The method of claim 21 wherein said maintenance probiotic is administered for said maintenance time period to provide from about 1×

10³ to about 1×

10¹² cfu of maintenance probiotic per day.

26. The method of claim 21 further comprising administering a dose of said botanical for said maintenance time period.

27. The method of claim 26 wherein said dose of said botanical for said maintenance time period comprises from about 0.001 g to about 100 g of said botanical per day.

28. The method of claim 21 further comprising administering an additional material or said maintenance time period.

29. The method of claim 28 wherein said additional material is administered in an amount of from about 0.001 μ

g to about 10 g of said additional material, per day.

30. The method of claim 1 further comprising administering a pre-loading composition for a pre-loading time period before said loading time period.

31. The method of claim 30 wherein said pre-loading composition is selected from the group consisting of:

a probiotic, a botanical, an additional material, and combinations thereof.

32. A method of administering a probiotic comprising the steps of:

a. administering a loading dose of a loading probiotic for a loading time period; and

b. administering a dose of an additional material for said loading time period.

33. The method of claim 32 wherein said additional material is selected from the group consisting of:

vitamins, minerals, metals, elements, essential fatty acids, essential amino acids, sensates, prebiotics, and combinations thereof.

34. A method of administering a probiotic comprising the steps of:

a. administering a loading dose of a loading probiotic for a loading time period;

b. administering a dose of a botanical for said loading time period; and

c. administering a dose of an additional material for said loading time period.

35. A method of administering a probiotic comprising the steps of:

a. administering a loading dose of a loading probiotic for a loading time period;

b. administering a dose of a botanical for said loading time period;

c. subsequently administering a dose of a maintenance probiotic for a maintenance time period.

36. The method of claim 35 further comprising administering a dose of a botanical for said maintenance time period.

37. The method of claim 35 further comprising administering a dose of an additional material for said loading time period.

38. The method of claim 35 further comprising administering a dose of an additional material for said maintenance time period.

39. The method of claim 35 further comprising, prior to steps a and b, administering a pre-loading composition for a pre-loading time period.

40. A method of administering a probiotic comprising the steps of:

a. administering a loading dose of a loading probiotic for a loading time period;

b. administering a dose of an additional material for said loading time period;

c. subsequently administering a dose of a maintenance probiotic for a maintenance time period.

41. The method of claim 40 further comprising administering a dose of an additional material for said maintenance time period.

42. The method of claim 40 further comprising administering a dose of a botanical for said loading time period.

43. The method of claim 40 further comprising administering a dose of a botanical for said maintenance time period.

44. The method of claim 40 further comprising, prior to steps a and b, administering a pre-loading composition for a pre-loading time period.

45. A kit for use in administering a probiotic comprising:

a. loading doses of a loading probiotic to be administered for a loading time period; and

b. doses of a botanical to be administered for said loading time period.

46. The kit of claim 45 further comprising instructions for use of said kit.

47. The kit of claim 45 further comprising a compliance aid.

48. The kit of claim 45 further comprising doses of an additional material to be administered for said loading time period.

49. The kit of claim 45 further comprising doses of a maintenance probiotic to be administered for a maintenance time period.

50. The kit of claim 49 further comprising doses of a botanical to be administered for said maintenance period time period.

51. The kit of claim 49 further comprising doses of an additional material to be administered for said maintenance time period.

52. The kit of claim 45 further comprising doses of a pre-loading composition to be administered for a pre-loading time period.

53. A kit for use in administering a probiotic comprising:

a. loading doses of a loading probiotic to be administered for a loading time period; and

b. doses of an additional material to be administered for said loading time period.

54. A kit for use in administering a probiotic comprising:

a. loading doses of a loading probiotic to be administered for a loading time period;

b. doses of a botanical to be administered for said loading time period; and

c. doses of an additional material to be administered for said loading time period.