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.

What is claimed is: 
     
         1 . A method for promoting development of beneficial gut flora in a subject in need thereof comprising administering to the subject a composition comprising concentrated human milk permeate thereby promoting the development of beneficial gut flora in the subject's gut;
 wherein the concentrated human milk permeate comprises a plurality of human milk oligosaccharides, and wherein the subject is an adult.   
     
     
         2 . The method of  claim 1 , wherein the plurality comprises at least 10 human milk oligosaccharides. 
     
     
         3 . The method of  claim 1 , wherein the plurality comprises at least 25 human milk oligosaccharides. 
     
     
         4 . The method of  claim 1 , wherein the composition is administered to the subject prior to, concurrently with, or following administration of an additional composition useful in promoting development of beneficial gut flora. 
     
     
         5 . The method of  claim 4 , wherein the additional composition useful in promoting development of beneficial gut flora is a probiotic composition or a composition comprising plant polysaccharides. 
     
     
         6 . The method of  claim 5 , wherein the additional composition useful in promoting development of beneficial gut flora is a probiotic composition. 
     
     
         7 . The method of  claim 6 , wherein the probiotic composition comprises Bifidobacteria,  Lactobacillus , or both. 
     
     
         8 . The method of  claim 1 , wherein the composition is administered orally. 
     
     
         9 . The method of  claim 1 , wherein the composition is administered orally via feeding tube. 
     
     
         10 . The method of claim of  claim 1 , wherein the subject is in need of treatment for inflammatory bowel disease. 
     
     
         11 . The method of  claim 1 , wherein the inflammatory bowel disease comprises irritable bowel disease, Crohn's disease, ulcerative colitis, microscopic colitis, collagenous colitis, necrotizing enterocolitis, indeterminant colitis, or pseudomembranous colitis. 
     
     
         12 . A method of making a concentrated human milk permeate composition, comprising,
 (i) removing cream from a pool of human milk comprising a plurality of human milk oligosaccharides to obtain pooled human skim milk;   (ii) ultra-filtering the pooled human skim milk to obtain human milk permeate, wherein the human milk permeate comprises the plurality of human milk oligosaccharides; and   (iii) concentrating the human milk permeate to increase the concentration of the human milk oligosaccharides;   thereby making a concentrated human milk permeate composition.   
     
     
         13 . The method of  claim 12 , wherein the method further comprises:
 (iv) pasteurizing the concentrated human milk permeate from step (iii).   
     
     
         14 . The method of  claim 12 , wherein the step (iii) comprises concentrating the human milk permeate with reverse osmosis. 
     
     
         15 . The method of  claim 12 , wherein the pool of human milk comprises a from about 75 liters to about 2000 liters of human milk. 
     
     
         16 . The method of  claim 12 , wherein the ultra-filtering of step (ii) comprises filtering through filters from about 1 kDa to about 1,000 kDa in size. 
     
     
         17 . The method of  claim 12 , wherein the pooled human milk has been genetically screened to identify viral contaminants. 
     
     
         18 . The method of  claim 17 , wherein the viral contaminants are HIV-1, HBV, and/or HCV. 
     
     
         19 . The method of  claim 17 , wherein the pooled human milk has been genetically screened by polymerase chain reaction (PCR).