Methods for decreasing the incidence of necrotizing enterocolitis in infants, toddlers, or children using human milk oligosaccharides
Inventors
Chow, JoMay • Davis, Steven R. • Buck, Rachael • Duska-McEwen, Geralyn O. • Linke, Hawley K.
Assignees
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Publication Number
US-12343355-B2
Publication Date
2025-07-01
Expiration Date
Abstract
Disclosed are methods of reducing the incidence of necrotizing enterocolitis in an infant, toddler, or child using nutritional compositions including human milk oligosaccharides. The nutritional compositions including the human milk oligosaccharides are effective in reducing inflammation and the incidence of inflammatory diseases.
Core Innovation
The invention relates to human milk oligosaccharide (HMO)-containing nutritional compositions and methods for reducing necrotizing enterocolitis (NEC) incidence. It uses HMOs in infant, toddler, and child nutritional formulations and/or fortifiers, with optional inclusion of prebiotics and/or probiotics, and targets gut-brain-immune stimulation as part of the mechanism of action.
The disclosed mechanism includes stimulation of enteric nerve cells, with emphasis on 2′-fucosyllactose and/or 3′-fucosyllactose. The patent also describes improved gut barrier integrity and reduction of inflammation as outcomes associated with HMO administration, and it describes synbiotic effects that promote beneficial microbiota.
The document provides HMO embodiments and blends, including 2′-fucosyllactose, 3′-fucosyllactose, 6′-sialyllactose, 3′-sialyllactose, and lacto-N-neotetraose (LNnT). It further describes ranges for total HMO amounts and example embodiments for nutritional compositions, including different formula formats and combinations with other nutritional components.
Claims Coverage
The partial content includes two independent claims, with five inventive features centered on a shelf-stable synthetic formula. Across the claims, the features are a specific oligosaccharide blend including 2′-fucosyllactose and another human milk oligosaccharide, a long-chain polyunsaturated fatty acid component with a defined DHA:ARA ratio, a monomeric monophosphate nucleotide component, shelf stability for at least 3 months, and in one claim lactodifucotetraose and specific free acid and salt forms of the nucleotide component.
Shelf-stable synthetic formula with an HMO-containing oligosaccharide blend including 2′-fucosyllactose
A shelf stable synthetic formula comprising from about 0.2 mg/mL to about 20 mg/mL of an oligosaccharide blend, wherein the oligosaccharide blend comprises a first human milk oligosaccharide and 2′-fucosyllactose, and wherein the synthetic formula is shelf stable for at least 3 months.
Long-chain polyunsaturated fatty acid component with defined DHA:ARA ratio
A shelf stable synthetic formula comprising from about 0.001 g/L to about 1 g/L of a long chain polyunsaturated fatty acid component comprising docosahexaenoic acid and arachidonic acid, wherein the ratio of docosahexaenoic acid to arachidonic acid is from about 1:4 to about 1:2.
Monomeric monophosphate nucleotide component
A shelf stable synthetic formula comprising from about 42 mg/L to about 200 mg/L of a monomeric monophosphate nucleotide component.
Lactodifucotetraose in the shelf-stable synthetic formula
A shelf stable synthetic formula including lactodifucotetraose, together with the specified oligosaccharide blend, long chain polyunsaturated fatty acid component, and monomeric monophosphate nucleotide component, wherein the synthetic formula is shelf stable for at least 3 months.
Monomeric monophosphate nucleotide component with free acid and salt forms
A shelf stable synthetic formula comprising a monomeric monophosphate nucleotide component wherein the monomeric monophosphate nucleotide component comprises at least one monomeric monophosphate nucleotide that is a free acid and at least one other monomeric monophosphate nucleotide that is a salt, together with the specified oligosaccharide blend and long chain polyunsaturated fatty acid component, wherein the synthetic formula is shelf stable for at least 3 months.
Taken together, the independent claims cover shelf-stable synthetic infant nutritional formulas characterized by a specified HMO-containing oligosaccharide blend with 2′-fucosyllactose and another human milk oligosaccharide, a DHA/ARA long-chain polyunsaturated fatty acid component with a defined ratio, and a monomeric monophosphate nucleotide component, with one independent claim also requiring lactodifucotetraose and another requiring both free-acid and salt forms.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Reducing necrotizing enterocolitis (NEC) incidence by administering HMO-containing nutritional compositions to infants, toddlers, and children [procedural detail omitted for safety].
Improving feeding tolerance in an infant, toddler, or child by administering the synthetic formula.
Improving gut function in an infant, toddler, or child by administering the synthetic formula.
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