HMO-Supplemented Infant Formula for CMPA Gut Microbiota Maturation

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Solution Overview

Problem

There is a need for nutritional compositions, such as infant formulas, that can prevent or reduce the premature maturation of the gut microbiota in infants with cow's milk protein allergy, without causing side effects and being easily accepted by parents and healthcare practitioners.

Innovation Solution

Supplementation of infant formulas with human milk oligosaccharides (HMOs) 2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) in extensively hydrolysed or amino acid-based formulas to inhibit or reduce premature maturation of the gut microbiota.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional infant formula is used, then the formula provides basic nutritional needs, but the gut microbiota matures prematurely and loses diversity

Engineering Contradiction:
Improvebasic nutritional provisionVSAvoidgut microbiota composition
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary action by adding HMOs (2'FL and LNnT) to the infant formula before feeding, which pre-establish conditions that prevent premature microbiota maturation. These oligosaccharides are incorporated into the formula composition in advance to modulate gut microbiota development from the earliest stages of formula feeding.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses HMOs as intermediary substances that mediate between the infant formula and the gut microbiota. These oligosaccharides act as prebiotics that selectively promote the growth of beneficial bacteria (Bifidobacterium and Lactobacillus) while preventing the premature establishment of adult-type microbiota, thus serving as a bridge that protects microbiota composition.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If breast milk is eliminated from the mother's diet to treat CMPA, then allergy symptoms are reduced, but the infant loses access to beneficial HMOs that support healthy microbiota

Engineering Contradiction:
Improveallergy symptomsVSAvoidHMOs intake
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The patent extracts and isolates specific beneficial HMOs (2'FL and LNnT) from breast milk and incorporates them directly into the infant formula. This allows the infant to receive the protective oligosaccharides without requiring the mother to breastfeed or restrict her diet, effectively separating the beneficial component from the allergenic proteins.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates a synthetic copy of the beneficial HMO profile found in breast milk by adding specific oligosaccharides (2'FL and LNnT) to the formula. This copied oligosaccharide profile replicates the microbiota-modulating effects of breast milk without requiring actual breast milk intake, thus providing the same protective benefits against premature microbiota maturation.

Inventive Principle:
Principle #26Copying

3Object-affected harmful factors

If extensively hydrolysed or amino acid-based formula is used to treat CMPA, then allergy symptoms are controlled, but the gut microbiota diversity and maturity are negatively affected

Engineering Contradiction:
ImproveCMPA symptomsVSAvoidmicrobiota diversity
Core Design Contradiction:
Object-affected harmful factorsVSStability of the object's composition

Solution Approach 1:

The patent merges two previously separate solutions into a single integrated formula: the hypoallergenic protein source (extensively hydrolysed or amino acid-based) is combined with added HMOs (2'FL and LNnT). This combination allows the formula to simultaneously provide allergy protection while also supporting healthy microbiota development, eliminating the need to choose between allergy management and microbiota health.

Inventive Principle:
Principle #5Merging (Combining)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The use of 2'FL and LNnT in infant formulas leads to lower microbial diversity and reduced gut microbiota age at 12 months, promoting a healthier gut microbiome and immune system development in infants with cow's milk protein allergy.

Implementation Method 1

HMOs may also function as soluble decoy receptors in the gut, protecting the neonate from enteric pathogens

Methodology Applied
Scientific EffectPrebiotic effect:

Implementation Method 2

HMOs may also function as soluble decoy receptors in the gut, protecting the neonate from enteric pathogens

Methodology Applied
Scientific EffectDecoy receptor mechanism:

Data Source

PatentEP4228435B1Infant or young child formula
Publication Date: 2026.01.28 SOCIETE DES PRODUITS NESTLE SA
  • EP4228435B1 patent drawingFigure 1A
  • EP4228435B1 patent drawingFigure 1B
  • EP4228435B1 patent drawingFigure 2A~2B

AI summary

The present invention relates to nutritional compositions for infants and young children comprising the human milk oligosaccharides (HMOs) 2'-fucosyllactose (2FL) and lacto-N- neotetraose (LNnT), for modulating maturation of the gut microbiome. The formula may be an extensively hydrolysed formula (eHFs) or an amino acid-based infant formula (AAFs) and may be used in an infant with cow's milk protein allergy.