Human milk permeate compositions and methods of making and using same

Abstract

This disclosure features human milk permeates and compositions containing the same obtained from fractionated whole human milk. The oligosaccharide rich permeate and permeate compositions of the present invention are useful as nutritional supplements for pre-term and full term infants, for establishing or maintaining gut flora and for treating the symptoms of inflammatory bowel disease.

1 - 11 . (canceled) 
     
     
         12 . A method of making a concentrated form of human milk permeate comprising human milk oligosaccharides, the method comprising:
 (a) obtaining human milk;   (b) separating the milk into cream and skim;   (c) filtering the skim to obtain a permeate;   (d) retaining the permeate; and   (e) concentrating the permeate.   
     
     
         13 - 15 . (canceled) 
     
     
         16 . The method of  claim 12  wherein the concentrating step in step (e) comprises reverse osmosis. 
     
     
         17 . The method of  claim 12 , further comprising adding vitamins and minerals to the permeate after step (d) 
     
     
         18 . The method of  claim 12  wherein the filtering comprises ultrafiltering. 
     
     
         19 . The method of  claim 12  further comprising (f) reducing the bioburden. 
     
     
         20 . The method of  claim 19  wherein reducing the bioburden comprises pasteurization or sterile filtration. 
     
     
         21 - 63 . (canceled) 
     
     
         64 . The method of  claim 12  wherein the human milk is pooled from two or more donors prior to step (b). 
     
     
         65 . The method of  claim 64  wherein the human milk is pooled to arrive at 75-2000 liters/lot of human milk. 
     
     
         66 . The method of  claim 18  wherein the ultrafiltering comprises filtering through filters about 1 Kda-1,000 Kda in size. 
     
     
         67 . The method of  claim 64  wherein the human milk is frozen prior to pooling. 
     
     
         68 . The method of  claim 64  wherein the pooled human milk is genetically screened to identify contaminants. 
     
     
         69 . The method of  claim 68  wherein the contaminants are viral contaminants. 
     
     
         70 . The method of  claim 69 , wherein the viral contaminants are HIV-1, HBV, and/or HCV. 
     
     
         71 . The method of  claim 68  wherein the pooled human milk is genetically screened by polymerase chain reaction (PCR). 
     
     
         72 . The method of  claim 64  wherein the pooled human milk is filtered through a 200 micron filter prior to step (b). 
     
     
         73 . The method of  claim 64  wherein the pooled human milk is heated to about 63° C. or greater for at least about 30 minutes prior to step (b).