PURIFIED HUMAN MILK OLIGOSACCHARIDES COMPOSITIONS
The present invention relates to purified and concentrated human milk oligosaccharide compositions and methods of making and using the same.
1 - 22 . (canceled)
23 . A method for preventing necrotizing enterocolitis in a subject in need thereof, the method comprising:
adding a purified human milk oligosaccharide composition to an infant formula to obtain a mixed infant formula, wherein the purified human milk composition comprises: at least 5% human milk oligosaccharides by weight/weight, less than or equal to 5% lactose by weight/weight, and at least ten structurally distinct human milk oligosaccharides; and
administering the mixed infant formula to a premature infant in need thereof.
24 . The method of claim 23 , wherein the purified human milk oligosaccharide composition comprises as least fifty structurally distinct human milk oligosaccharides.
25 . The method of claim 23 , wherein the purified human milk oligosaccharide composition comprises at least one neutral human milk oligosaccharide and at least one sialylated human milk oligosaccharide.
26 . The method of claim 23 , wherein the purified human milk oligosaccharide composition comprises at least one human milk oligosaccharide comprising an α1-2 linked fucose and at least one human milk oligosaccharide comprising α1-4 linked fucose.
27 . The method of claim 23 , wherein the purified human milk oligosaccharide composition comprises 2′-fucosyllactose (2′FL), 3-fucosyllactose (3′FL), lacto-N-difucohexaose (LNDFH), lacto-N-fucopentaitol I (LNFP I), lacto-N-tetraose (LNT), 3′-sialyllactose (3′SL), 6′-sialyllactose (6′SL), sialyllacto-N-tetraose c (LSTc), sialyllacto-N-tetraose b (LSTb), and disialyllacto-N-tetraose (DSLNT).
28 . A method of making a purified human milk oligosaccharide composition comprising:
(a) mixing human milk permeate with lactase under conditions suitable for the digestion of lactose in the human milk permeate to create a permeate/lactase mixture, wherein the human milk permeate is obtained from the ultrafiltration of human skim milk;
(b) removing the lactase from the permeate/lactase mixture; and
(c) filtering the mixture to purify and concentrate human milk oligosaccharides.
29 . The method of claim 28 , wherein the pH of the permeate is adjusted to a pH of about 4.3 to about 4.7 prior to or concurrent with the addition of the lactase.
30 . The method of claim 28 , wherein the permeate is heated to a temperature of about 45° C. to about 55° C. prior to or concurrent with the addition of the lactase.
31 . The method of claim 28 , wherein lactase is added at about 0.1% to about 0.5% weight/weight.
32 . The method of claim 28 , further comprising cooling the mixture to a temperature of about 20° C. to about 30° C. prior to the removal of lactase.
33 . The method of claim 28 , further comprising clarifying the lactase digested permeate through a depth filter, wherein the depth filter is about 1 to about 5 micron filter.
34 . The method of claim 28 , wherein the filtering comprises filtering the mixture of step (b) through a membrane having a pore size of about 50,000 Dalton to create a 50,000 Dalton filtered mixture.
35 . The method of claim 34 , further comprising filtering the 50,000 Dalton filtered mixture through a membrane having a pore size of about 2,000 Dalton to about 3,000 Dalton to create a 2,000 to 3,000 Dalton filtered mixture.
36 . The method of claim 34 , further comprising filtering the 50,000 Dalton filtered mixture through a membrane having a pore size of ≤600 Dalton.
37 . The method of claim 28 , wherein the concentration of human milk oligosaccharides after purification in step (c) is at least 5% weight/weight.
38 . The method of claim 28 , wherein the concentration of human milk oligosaccharides after purification in step (c) is about 1% to about 5% weight/weight.
39 . A purified human milk oligosaccharide (HMO) composition made according to the method of claim 28 .
40 . A method for decreasing systemic inflammation in a subject in need thereof comprising administering to the subject an effective amount of the purified HMO composition of claim 39 .
41 . A method for treating or preventing graft versus host disease in a subject in need thereof comprising administering to the subject an effective amount of the purified HMO composition of claim 39 .
42 . A method for treating or preventing graft versus host disease in a subject in need thereof, the method comprising:
orally administering to the subject an effective amount of a purified human milk oligosaccharide composition, wherein the subject is an adult who has had or will receive a bone marrow or an organ transplant, thereby treating or preventing the graft versus host disease;
wherein the purified human milk composition comprises: at least 5% human milk oligosaccharides by weight/weight, less than or equal to 5% lactose by weight/weight, and at least ten structurally distinct human milk oligosaccharides.