Methods for decreasing the incidence of necrotizing enterocolitis in infants, toddlers, or children using human milk oligosaccharides

• US 9,539,269 B2
• Filed: 12/22/2011
• Issued: 01/10/2017
• Est. Priority Date: 12/31/2010
• Status: Active Grant

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Chow, JoMay, Davis, Steven R., Buck, Rachael, Duska-McEwen, Geralyn O., Linke, Hawley K.
• Primary Examiner(s): LEWIS, PATRICK T
• Application Number:
  US13/334,933
• Publication Number:
  US 20120172319A1
• Time in Patent Office: 1,846 Days
• Field of Search: 514/53, 514/54
• US Class Current: 1/1
• CPC Class Codes: A23L 33/10 using additives addition of substantially indigestible substances A23L33/21
• CPC Class Codes: A23L 33/12 Fatty acids or derivatives thereof
• CPC Class Codes: A23L 33/135 Bacteria or derivatives thereof, e.g. probiotics
• CPC Class Codes: A23L 33/19 Dairy proteins
• CPC Class Codes: A23L 33/30 Dietetic or nutritional methods, e.g. for losing weight A23L33/10 takes precedence
• CPC Class Codes: A23L 33/40 Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
• CPC Class Codes: A23V 2002/00 Food compositions, function of food ingredients or processes for food or foodstuffs
• CPC Class Codes: A23V 2200/32 having an effect on the health of the digestive tract
• CPC Class Codes: A23V 2250/282 Oligosaccharides, digestible
• CPC Class Codes: A61K 2035/11 Medicinal preparations comprising living procariotic cells
• CPC Class Codes: A61K 2035/115 Probiotics
• 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 31/702 Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
• CPC Class Codes: A61K 31/716 Glucans
• CPC Class Codes: A61K 31/733 Fructosans, e.g. inulin
• CPC Class Codes: A61K 35/20 Milk; Whey; Colostrum
• CPC Class Codes: A61K 35/744 Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
• 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 36/48 Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
• CPC Class Codes: A61K 38/018 : from milk
• CPC Class Codes: A61K 45/06 : Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/107 : Emulsions ; Emulsion preconcentrates; Micelles composition of emulsions A61K47/00
• CPC Class Codes: A61P 1/00 : Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 3/02 : Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 39/06 : Free radical scavengers or antioxidants

Abstract

Disclosed are methods of reducing the incidence of necrotizing enterocolitis in an infant, toddler, or child using nutritional compositions including human milk oligosaccharides. The nutritional compositions including the human milk oligosaccharides are effective in reducing inflammation and the incidence of inflammatory diseases.

Claims

1. A method of reducing the incidence of necrotizing enterocolitis in an infant, toddler, or child, the method comprising administering to an infant, toddler, or child in need thereof, a nutritional composition comprising human milk oligosaccharides selected from the group consisting of 2′

-fucosyllactose, lacto-N-neotetraose, and combinations thereof in a total amount of from about 0.001 mg/mL to about 20 mg/mL.

2. The method of claim 1, wherein the composition comprises from 0.001 mg/mL to less than 2 mg/mL 2′

-fucosyllactose.

3. The method of claim 1, wherein the composition comprises from 0.001 mg/mL to less than 0.2 mg/mL lacto-N-neotetraose.

4. The method of claim 1, wherein the composition further comprises at least one of a prebiotic, a probiotic, a long chain polyunsaturated fatty acid, an antioxidant, a milk protein of human origin, a milk protein of bovine origin, and a milk protein of combined bovine and human origin.

5. A method of reducing the incidence of necrotizing enterocolitis in an infant, toddler, or child, the method comprising administering to an infant, toddler, or child in need thereof a nutritional composition comprising 6′

-sialyllactose, 2′

-fucosyllactose, and lacto-N-neotetraose wherein the 6′

-sialyllactose, 2′

-fucosyllactose, and lacto-N-neotetraose are present in a total amount of from about 0.001 mg/mL to about 20 mg/mL.

6. The method of claim 5, wherein the nutritional composition comprises from 0.001 mg/mL to less than 0.25 mg/mL 6′

-sialyllactose.

7. The method of claim 5, wherein the nutritional composition comprises from 0.001 mg/mL to less than 2 mg/mL 2′

-fucosyllactose.

8. The method of claim 5, wherein the nutritional composition comprises from 0.001 mg/mL to less than 0.2 mg/mL lacto-N-neotetraose.

9. The method of claim 5, wherein the synthetic nutritional composition further comprises at least one of a prebiotic, a probiotic, a long chain polyunsaturated fatty acid, an antioxidant, and a milk protein of human origin, a milk protein of bovine origin, and a milk protein of combined bovine and human origin.

10. A synthetic formula for improving the feeding tolerance of an infant, toddler, or child, the synthetic formula comprising from about 0.001 mg/mL to about 20 mg/mL of an oligosaccharide blend and an emulsifying agent, wherein the oligosaccharide blend comprises a first oligosaccharide selected from the group consisting of a fructooligosaccharide, a galactooligosaccharide, lacto-N-neotetraose, 2′

-fucosyllactose, and combinations thereof;

a second oligosaccharide selected from the group consisting of 3′

-sialyllactose, 6′

-sialyllactose, and combinations thereof; and

a third oligosaccharide selected from the group consisting of inulin, a gum, polydextrose, and combinations thereof.

11. The synthetic formula of claim 10, wherein the oligosaccharide blend comprises from about 0.001 mg/mL to about 20 mg/mL of the first oligosaccharide, from about 0.001 mg/mL to about 20 mg/mL of the second oligosaccharide, and from about 0.05 mg/mL to about 20 mg/mL of the third oligosaccharide.

12. The synthetic formula of claim 10, wherein the first oligosaccharide comprises lacto-N-neotetraose in a concentration of from 0.01 mg/mL to less than 0.2 mg/mL.

13. The synthetic formula of claim 10, wherein the first oligosaccharide comprises lacto-N-neotetraose in a concentration of from greater than 0.32 mg/mL to 10 mg/mL.

14. The synthetic formula of claim 10, wherein the first oligosaccharide comprises 2′

-fucosyllactose in a concentration of from 0.001 mg/mL to less than 2.0 mg/mL.

15. The synthetic formula of claim 10, wherein the first oligosaccharide comprises 2′

-fucosyllactose in a concentration of from greater than 2.5 mg/mL to 10 mg/mL.

16. The synthetic formula of claim 10, wherein the second oligosaccharide comprises 6′

-sialyllactose in a concentration of from 0.001 mg/mL to less than 0.25 mg/mL.

17. The synthetic formula of claim 10, wherein the second oligosaccharide comprises 6′

-sialyllactose in a concentration of from greater than 0.4 mg/mL to 10 mg/mL.

18. A method of improving the feeding tolerance of an infant, toddler, or child in need thereof, the method comprising administering to the infant, toddler, or child a nutritional composition comprising from about 0.001 mg/mL to about 20 mg/mL of an oligosaccharide blend, wherein the oligosaccharide blend comprises a first oligosaccharide selected from the group consisting of a fructooligosaccharide, a galactooligosaccharide, lacto-N-neotetraose, 2′

-fucosyllactose, and combinations thereof;

a second oligosaccharide selected from the group consisting of 3′

-sialyllactose, 6′

-sialyllactose, and combinations thereof; and

a third oligosaccharide selected from the group consisting of inulin, a gum, polydextrose, and combinations thereof.