M-63 Infant Probiotic Composition for Early Gut Colonization

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Solution Overview

Problem

The intestinal microbiota in newborns, infants, and small children is unstable and prone to disturbances, leading to a high risk of infection and other health issues, and existing probiotics like Bifidobacterium longum subsp. infantis M-63 have not fully addressed the need for promoting early colonization and maintaining a healthy intestinal environment.

Innovation Solution

A composition containing Bifidobacterium longum subsp. infantis M-63, in the form of bacterial cells, cultures, or treated products, is administered to healthy full-term newborns, infants, or small children to promote early colonization, maturation of intestinal function, suppress milk regurgitation, and regulate immune function, preferably at a dosage of 1.0×10^8 to 5.0×10^9 cfu/kg body weight/day, often in combination with breast feeding.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If Bifidobacterium longum subsp. infantis M-63 is administered to promote colonization, then the intestinal environment is improved, but the stability of the intestinal microbiota remains insufficient in newborns and infants

Engineering Contradiction:
Improvestability of intestinal microbiotaVSAvoidintestinal microbiota composition
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent changes the key parameter from simply administering any Bifidobacterium to administering a specifically selected strain (B. longum subsp. infantis M-63) with optimized characteristics. This strain selection represents a parameter change that ensures both colonization promotion and microbiota stability, resolving the contradiction between improving the intestinal environment and maintaining microbiota stability.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If probiotics are administered to establish Bifidobacterium-dominant microbiota, then intestinal health is improved, but the risk of infection and disturbances remains high in the neonatal period

Engineering Contradiction:
Improveinfection riskVSAvoidintestinal microbiota stability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent applies preliminary action by administering the selected Bifidobacterium strain during the neonatal period and early infancy when the intestinal microbiota is still developing. This early intervention establishes a stable, Bifidobacterium-dominant microbiota before harmful disturbances can occur, thereby reducing infection risk while ensuring microbiota reliability.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses a specific, well-characterized strain (M-63) that can be reliably produced and administered as a standardized probiotic product. This approach replaces the need for complex, unstable natural microbiota transfers with a consistent, controllable probiotic intervention that provides reliable protection against infections.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Productivity

If existing probiotics are used, then some intestinal benefits are achieved, but early colonization promotion and intestinal maturation are not fully addressed

Engineering Contradiction:
Improveintestinal maturation rateVSAvoidcolonization effectiveness
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent applies local quality by selecting a probiotic strain specifically adapted to infant intestinal conditions. The B. longum subsp. infantis M-63 strain possesses local characteristics (infant-specific adaptation) that enable it to effectively colonize and promote intestinal maturation in the unique environment of the infant gut, achieving both high productivity in maturation and reliability in colonization.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP4616725A1Composition for newborns or infants
Publication Date: 2025.09.17 MORINAGA MILK IND CO LTD
  • EP4616725A1 patent drawingFigure 1
  • EP4616725A1 patent drawingFigure 2(a)~2(c)
  • EP4616725A1 patent drawingFigure 3(a)~3(c)

AI summary

An object is to provide a new function of Bifidobacterium longum subsp. infantis M-63 (NITE BP-02623). One kind or two or more kinds selected from bacterial cells of Bifidobacterium longum subsp. infantis M-63 (NITE BP-02623), a culture of the bacterium and a treated product of the bacterium is added to a composition taken by a healthy full-term newborn, infant or small child as an active ingredient. The composition is subjected to use for promoting colonization of a strain of Bifidobacterium in an intestinal microbiota, use for promoting maturation of an intestinal function, use for suppressing milk regurgitation or use for regulating immune function.