STAGED NUTRITIONAL COMPOSITIONS CONTAINING HUMAN MILK OLIGOSACCHARIDES AND USES THEREOF

Abstract

The present application provides nutritional compositions comprising human milk oligosaccharides, for use in providing nutrition to infants at different age stages.

Claims

1. An age-specific nutritional composition system comprising: at least one stage 1 nutritional composition for infants from 0 to 6 months of age; and, at least one stage 2 nutritional composition for infants from 6 to 12 months of age, wherein the stage 1 and stage 2 nutritional compositions comprise human milk oligosaccharides, wherein the human milk oligosaccharides comprise 2′-fucosyllactose (2FL), 3′-fucosyllactose (3FL), lacto-N-tetraose (LNT), 6′-sialyllactose (6SL), and 3′-sialyllactose (3SL), and wherein the stage 1 and stage 2 nutritional compositions comprise different amounts of one or more of the human milk oligosaccharides.

2. The nutritional composition system of claim 1, wherein, relative to the stage 2 nutritional composition, the stage 1 nutritional composition comprises a greater amount of 2FL, a smaller amount of 3FL, a greater amount of LNT, a smaller amount of 3 SL, a greater amount of 6SL, or any combination thereof.

3. The nutritional composition system of claim 1, wherein the stage 1 and stage 2 nutritional compositions comprise: TABLE-US-00017 Stage 1 (g/L) Stage 2 (g/L) 2FL 1.5-4  1.3-2   3FL 0.1-2  0.5-2.2 LNT   1-4.2 0.5-1.7 3SL 0.01-0.2  0.1-0.35 6SL  0.01-0.45 0.01-0.1 

4-7. (canceled)

8. The nutritional composition system of claim 1, wherein at least one of the nutritional compositions comprises a long-chain polyunsaturated fatty acid, preferably the long-chain polyunsaturated fatty acid comprises docosahexaenoic acid, arachidonic acid, or a combination thereof.

9. The nutritional composition system of claim 1, wherein at least one of the nutritional compositions comprises a probiotic, preferably the probiotic comprises Bifidobacterium longum subsp. infantis, Lactobacillus rhamnosus GG (ATCC number 53103), or a combination thereof.

10. The nutritional composition system of claim 1, wherein at least one of the nutritional compositions comprises a prebiotic, preferably the prebiotic comprises polydextrose, galactooligosaccharides, or a combination thereof.

11. The nutritional composition system of claim 1, wherein at least one of the nutritional compositions comprises lactoferrin.

12. The nutritional composition system of claim 1, wherein at least one of the nutritional compositions of the nutritional composition system is a synthetic nutritional composition.

13. The nutritional composition system of claim 1, for use in providing nutrition to an infant.

14-16. (canceled)

17. The nutritional composition system of claim 1, wherein the stage 1 nutritional composition comprises: 1.5 g/L to 4 g/L of 2FL; 0.1 g/L to 2 g/L of 3FL; 1 g/L to 4.2 g/L of LNT; 0.01 g/L to 0.2 g/L of 3SL; and, 0.01 g/L to 0.45 g/L of 6SL.

18. (canceled)

19. The nutritional composition system of claim 1, wherein the stage 2 nutritional composition comprises: 1.3 g/L to 2 g/L of 2FL; 0.5 g/L to 2.2 g/L of 3FL; 0.5 g/L to 1.7 g/L of LNT; 0.1 g/L to 0.35 g/L of 3SL; and, 0.01 g/L to 0.1 g/L of 6SL.

20-21. (canceled)

22. A staged feeding regimen, comprising the steps of: a) administering a stage 1 nutritional composition to an infant between 0 and 6 months of age; b) administering a stage 2 nutritional composition to an infant between 6 and 12 months of age, wherein the stage 1 and stage 2 nutritional compositions comprise human milk oligosaccharides, wherein the human milk oligosaccharides comprise 2FL, 3FL, LNT, 3SL, and 6SL, wherein the stage 1 and stage 2 nutritional compositions comprise different amounts of one or more of the human milk oligosaccharides.

23. The staged feeding regimen of claim 22, wherein the stage 1 and stage 2 nutritional compositions comprise: Stage 1 (g/L) Stage 2 (g/L) 2FL 1.5-4 1.3-2 3FL 0.1-2 0.5-2.2 LNT 1-4.2 0.5-1.7 3SL 0.01-0.2 0.1-0.35 6SL 0.01-0.45 0.01-0.1

24-25. (canceled)

26. An infant nutrition kit comprising a set of nutritional compositions according to claim 1.

Description

DESCRIPTION OF FIGURES

[0173] FIG. 1: Plot of how neutral HMO concentration changes over time in the breast milk of: a) secretor mothers; b) non-secretor mothers.

[0174] FIG. 2: Plot of how acidic HMO concentration changes over time in the breast milk of: a) secretor mothers; b) non-secretor mothers.

EXPERIMENTAL PROCEDURE

Sample Collection/Study Details

[0175] 94 mother-infant pairs were recruited from a single maternity hospital as part of the Cambridge Baby Growth Study (CBGS). All infants were vaginally born and exclusively breastfed until at least 6 weeks of age. Other inclusion criteria were: singleton; term gestation; no antibiotic and steroid history at least in the 30 days before delivery, no significant maternal illness, no regular use of probiotics during pregnancy; and, normal maternal pre-pregnancy BMI. 91.5% of study participants were Caucasian. The study was approved by the Cambridge Local Research Ethics Committee, and all mothers gave written consent. Breastfed mothers were asked to hand express hind milk samples after feeding their infants at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months postnatally. Expression was done from the same breast last used to feed their infants. Samples were kept frozen until processed at a single time point.

HMO Level Quantification

[0176] Five neutral HMOs (3-fucosyllactose, 2-fucosyllactose, lacto-N-fucopentaose I, lacto-N-tetraose, and lacto-N-neotetraose) and two acidic HMOs (6-sialyllactose and 3-sialyllactose) were quantified in 164 human hind milk samples, originating from 71 healthy lactating mothers. Quantification was conducted by high-performance anion-exchange chromatography with pulsed amperometric detection, using an expedited ‘dilute-and-shoot’ on-line sample clean-up method.

Example Compositions

[0177] The below compositions are to be illustrate some Examples of nutritional compositions within the scope of the present disclosure, but are in no way intended to provide any limitation on the disclosure.

TABLE-US-00013 TABLE 13 Component Nutritional composition for 0 to 3 months of age (Amount (g/L)) I II III IV V VI VII VIII IX X 2FL (1.5-4) X ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 3FL (0.1-1.5) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ LNT (1-4.2) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 3SL (0.01-0.15) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 6SL (0.05-0.45) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ LGG X X ✓ X X X X X X ✓ B. infantis X X X ✓ X X X X X ✓ PDX X X X X ✓ X X X ✓ ✓ GOS X X X X ✓ X X X ✓ ✓ DHA X X X X X ✓ ✓ X ✓ ✓ ARA X X X X X X ✓ X ✓ ✓ Lactoferrin X X X X X X X ✓ X ✓ Key: ✓ = present; X = not present

TABLE-US-00014 TABLE 14 Component Nutritional composition for 0 to 6 months of age (Amount (g/L)) I II III IV V VI VII VIII IX X 2FL (1.5-4) X ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 3FL (0.1-2) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ LNT (1-4.2) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 3SL (0.01-0.2) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 6SL (0.01-0.45) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ LGG X X ✓ X X X X X X ✓ B. infantis X X X ✓ X X X X X ✓ PDX X X X X ✓ X X X ✓ ✓ GOS X X X X ✓ X X X ✓ ✓ DHA X X X X X ✓ ✓ X ✓ ✓ ARA X X X X X X ✓ X ✓ ✓ Lactoferrin X X X X X X X ✓ X ✓ Key: ✓ = present; X = not present

TABLE-US-00015 TABLE 15 Component Nutritional composition for 3 to 6 months of age (Amount (g/L)) I II III IV V VI VII VIII IX X 2FL (1.5-2.2) X ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 3FL (0.3-2) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ LNT (0.7-2) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 3SL (0.05-0.2) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 6SL (0.01-0.18) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ LGG X X ✓ X X X X X X ✓ B. infantis X X X ✓ X X X X X ✓ PDX X X X X ✓ X X X ✓ ✓ GOS X X X X ✓ X X X ✓ ✓ DHA X X X X X ✓ ✓ X ✓ ✓ ARA X X X X X X ✓ X ✓ ✓ Lactoferrin X X X X X X X ✓ X ✓ Key: ✓ = present; X = not present

TABLE-US-00016 TABLE 16 Component Nutritional composition for 6 to 12 months of age (Amount (g/L)) I II III IV V VI VII VIII IX X 2FL (1.3-2) X ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 3FL (0.5-2.2) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ LNT (0.5-1.7) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 3SL (0.1-0.35) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ 6SL (0.01-0.1) ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ LGG X X ✓ X X X X X X ✓ B. infantis X X X ✓ X X X X X ✓ PDX X X X X ✓ X X X ✓ ✓ GOS X X X X ✓ X X X ✓ ✓ DHA X X X X X ✓ ✓ X ✓ ✓ ARA X X X X X X ✓ X ✓ ✓ Lactoferrin X X X X X X X ✓ X ✓ Key: ✓ = present; X = not present