Maternal Allergen Dosing to Prevent Infant Food Sensitization

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Solution Overview

Problem

There is a need for effective methods to prevent sensitization to food allergens such as milk or peanut protein in subjects, particularly through maternal consumption during pregnancy or breastfeeding, as existing guidelines lack evidence for hydrolyzed formula prevention and whole milk protein supplementation has shown mixed results.

Innovation Solution

Administering a composition containing an effective amount of food allergen, such as peanut or milk protein, to a mother during pregnancy or breastfeeding to prevent sensitization in the subject, with encapsulation to reduce gastrointestinal degradation and multiple administrations to reduce IgE titers and wheal size.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If hydrolyzed formula is administered to prevent food allergies, then prevention ability is improved, but evidence support is insufficient

Engineering Contradiction:
Improveprevention abilityVSAvoidevidence support
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent changes the parameter of allergen form from hydrolyzed to intact, and changes the timing of administration to prenatal and early postnatal periods. This parameter change is supported by emerging evidence that intact allergen exposure during critical developmental windows may be more effective for prevention than hydrolyzed formulas.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If whole milk protein formula is administered to prevent milk allergy, then protection against milk allergy is improved, but evidence from randomized controlled trials is lacking

Engineering Contradiction:
Improveprotection against milk allergyVSAvoidevidence from randomized controlled trials
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by administering intact milk protein to the mother during pregnancy and/or early breastfeeding, before the infant is fully exposed to dietary antigens. This early exposure during critical immune development may establish tolerance preemptively, addressing the lack of RCT evidence by proactively preventing sensitization before it occurs.

Inventive Principle:
Principle #10Preliminary action

3Object-affected harmful factors

If allergen avoidance is practiced during pregnancy and breastfeeding, then allergen exposure is reduced, but sensitization prevention is compromised

Engineering Contradiction:
Improveallergen exposureVSAvoidsensitization prevention
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent inverts the conventional allergen avoidance approach by recommending intentional allergen exposure through maternal consumption during pregnancy and breastfeeding. This inversion is based on the hypothesis that early, controlled exposure to intact allergens during critical immune development windows promotes oral tolerance rather than sensitization.

Inventive Principle:
Principle #13The other way round (Inversion)

4Ease of operation

If brief infant formula supplementation is administered in immediate post-natal period, then feeding flexibility is improved, but risk of cow's milk allergic outcomes is increased

Engineering Contradiction:
Improvefeeding flexibilityVSAvoidrisk of cow's milk allergic outcomes
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by having the mother consume the allergen before the infant receives formula supplementation. This ensures the infant is pre-exposed to allergen via breast milk, which may prime the immune system for tolerance, thereby reducing the risk of allergic outcomes even when formula supplementation is necessary for feeding flexibility.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20250339515A1Methods for preventing food sensitization
Publication Date: 2025.11.06 MY OR DIAGNOSTICS LTD
  • US20250339515A1 patent drawing
  • US20250339515A1 patent drawing
  • US20250339515A1 patent drawing

AI summary

The present invention relates a method for preventing sensitization to a food allergen, such as including peanut protein and/or milk protein, in a subject in need thereof, including administering a composition including a low level of a food allergen, such as including a peanut protein and/or milk protein, to a mother breastfeeding the subject, thereby preventing sensitization to a food allergen, in the subject.