Human milk compositions and methods of making and using same

Abstract

The disclosure features human milk fortifier compositions, standardized human milk, and methods of making and using same. In one embodiment, a pasteurized human milk composition includes a human protein constituent of about 35-85 mg/mL; a human fat constituent of about 60-110 mg/mL; and a human carbohydrate constituent of about 60-140 mg/mL.

What is claimed is: 
     
         1 . A human milk composition prepared by a method comprising adding a human milk fortifier to a volume of human milk, wherein the addition of the human milk fortifier increases the caloric content of the human milk by about 6-10 Cal/oz. 
     
     
         2 . The human milk composition of  claim 1 , wherein the human milk fortifier does not comprise xenogeneic components. 
     
     
         3 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises about 35-85 mg/mL protein. 
     
     
         4 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises about 55-65 mg/mL protein. 
     
     
         5 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises about 60-110 mg/mL fat. 
     
     
         6 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises about 85-95 mg/mL fat. 
     
     
         7 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises about 60-140 mg/mL carbohydrates. 
     
     
         8 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises about 70-120 mg/mL carbohydrates. 
     
     
         9 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises about 55-65 mg/mL protein, about 85-95 mg/mL fat, and about 70-120 mg/mL carbohydrates. 
     
     
         10 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises about 2.5-4.25 mg/mL calcium. 
     
     
         11 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises about 1.25-2.25 mg/mL phosphorous. 
     
     
         12 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises a calcium to phosphorus ratio of no more than 2:1. 
     
     
         13 . The human milk composition of  claim 1 , wherein the human milk fortifier comprises a calcium to phosphorus ratio of about 1.8:1 to about 2:1. 
     
     
         14 . The human milk composition of  claim 1 , wherein the human milk fortifier is added to the volume of human milk at a milk:fortifier ratio of about 70:30. 
     
     
         15 . The human milk composition of  claim 1 , wherein the human milk fortifier is added to the volume of human milk at a milk:fortifier ratio of about 60:40. 
     
     
         16 . The human milk composition of  claim 1 , wherein the human milk fortifier is added to the volume of human milk at a milk:fortifier ratio of about 50:50. 
     
     
         17 . The human milk composition of  claim 1 , wherein the human milk fortifier is prepared from donor milk obtained from a qualified human breast milk donor. 
     
     
         18 . The human milk composition of  claim 17 , wherein the donor is qualified by screening a biological sample from the donor for the presence of pathogens and drugs of abuse. 
     
     
         19 . The human milk composition of  claim 18 , wherein the pathogens are selected from HIV 1, HIV2, HTLV I, HTLV II, HBV, HCV, syphilis, and  B. cereus.    
     
     
         20 . The human milk composition of  claim 18 , wherein the drugs of abuse are selected from the group consisting of cocaine, opiates, methamphetamines, benzodiazepine, amphetamines, and THC. 
     
     
         21 . The human milk composition of  claim 17 , wherein the donor is requalified periodically. 
     
     
         22 . The human milk composition of  claim 17 , wherein a biological sample from the qualified human breast milk donor is tested for one or more genetic markers. 
     
     
         23 . The human milk composition of  claim 22 , wherein the donor milk is tested for one or more genetic markers, and wherein the genetic markers of the donor milk are compared to the genetic markers of the biological sample from the qualified human breast milk donor, to determine if the donor milk is obtained from the qualified human breast milk donor. 
     
     
         24 . The human milk composition of  claim 1 , wherein the human milk fortifier is prepared from donor milk from a qualified human breast milk donor, wherein the donor milk is screened for the presence of pathogens and drugs of abuse prior to preparing the human milk fortifier. 
     
     
         25 . The human milk composition of  claim 24 , wherein the pathogens are selected from the group consisting of HIV 1, HIV2, HTLV I, HTLV II, HBV, HCV, syphilis, and  B. cereus.    
     
     
         26 . The human milk fortifier composition of  claim 1 , prepared by pooling milk from a human donor to generate the fortifier composition, wherein the donor milk is pooled to at least about 75 to 2,000 liters per lot. 
     
     
         27 . The human milk composition of  claim 1 , prepared by pooling milk from a human donor and concentrating the nutrients in the pooled milk to obtain the human milk fortifier composition. 
     
     
         28 . The human milk composition of  claim 27 , wherein the concentrating step comprises filtration. 
     
     
         29 . The human milk composition of  claim 27 , wherein the filtering comprises ultrafiltration. 
     
     
         30 . The human milk composition of  claim 1 , wherein the human milk fortifier is prepared by pooling milk from a human donor and processing the donor milk to reduce the bioburden. 
     
     
         31 . The human milk composition of  claim 29 , wherein the bioburden of the pooled human milk is reduced by heat treatment. 
     
     
         32 . The human milk composition of  claim 29 , wherein the bioburden of the pooled human milk is reduce by filtration. 
     
     
         33 . The human milk composition of  claim 1 , wherein the human milk fortifier is prepared by a method comprising pooling milk from a qualified human donor, screening the pooled milk for the presence of pathogens, and filtering the pooled milk. 
     
     
         34 . The human milk composition of  claim 32 , wherein the filtering comprises ultrafiltration. 
     
     
         35 . The human milk composition of  claim 32 , wherein the method further comprises pasteurization. 
     
     
         36 . The human milk composition of  claim 32 , wherein the method further comprises separating the pooled milk into a skim portion and a cream portion. 
     
     
         37 . The human milk composition of  claim 35 , wherein the method further comprises filtering the skim portion through one or more skim filters to obtain a permeate portion and a protein rich skim portion; and mixing a fraction of the cream portion with the protein rich skim portion. 
     
     
         38 . The human milk composition of  claim 36 , wherein the method further comprises washing the one or more skim filters with permeate to obtain a protein wash, and adding the protein wash to the protein rich skim portion. 
     
     
         39 . A method for providing fortified human milk to a preterm or low birth weight infant, comprising administering the human milk composition of  claim 1  to the premature or low birth weight infant. 
     
     
         40 . The method of  claim 38 , wherein the infant was born at less than 37 weeks gestational age. 
     
     
         41 . The method of  claim 38 , wherein the infant weighs less than 2500 grams at birth. 
     
     
         42 . The method of  claim 38 , wherein the infant weighs less than 1500 grams at birth. 
     
     
         43 . The method of  claim 38 , wherein the human milk composition is administered to the infant as a bolus feeding or through a syringe infusion pump for continuous feeding. 
     
     
         44 . A method for promoting growth of a preterm or low birth weight infant, comprising administering the human milk composition of  claim 1  to the premature or low birth weight infant. 
     
     
         45 . A method for promoting the immunological development of a preterm or low birth weight infant, comprising administering the human milk composition of  claim 1  to the premature or low birth weight infant. 
     
     
         46 . A method for treating or preventing necrotizing enterocolitis (NEC) in a preterm or low birth weight infant, comprising administering the human milk composition of  claim 1  to the premature or low birth weight infant. 
     
     
         47 . A method for preparing a fortified human milk composition comprising adding a human milk fortifier to a volume of human milk, wherein the fortifier comprises a caloric content of about 1.35-1.55 Cal/mL, and wherein the fortifier is mixed with the volume of human milk at a milk:fortifier ratio of about 70:30, about 60:40, or about 50:50.