Bacillus subtilis Spore Probiotic for Gastrointestinal Regularity

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Solution Overview

Problem

Current probiotic products often fail to effectively treat gastrointestinal irregularities due to deficiencies in probiotic strain viability, particularly in products containing bifidobacteria, and struggle to maintain healthy gut microflora in the face of gastric acid and bile acid barriers.

Innovation Solution

Administration of Bacillus subtilis DE111®, a spore-forming probiotic strain, in doses ranging from 1·108 CFU to 1·1011 CFU per day for at least 15 to 90 days to treat, maintain, promote, and restore gastrointestinal regularity, utilizing its ability to form spores that protect against harsh conditions and promote colonization in the GI tract.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional probiotic products containing bifidobacteria are used, then they are administered to treat gastrointestinal irregularities, but they fail to maintain viability due to gastric acid and bile acid barriers

Engineering Contradiction:

Improveprobiotic strain viabilityVSAvoidgastric acid and bile acid exposure

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the physiological state of the probiotic bacteria from vegetative to spore-forming. Spores have different physical and chemical properties that make them resistant to gastric acid and bile acids, allowing them to survive the harsh gastrointestinal environment and maintain viability throughout digestion and colonization processes

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent utilizes the harsh gastrointestinal conditions (gastric acid and bile acids) that normally kill conventional probiotics as a selection pressure that favors spore-forming bacteria. The spores not only survive these harmful conditions but use them as signals to trigger germination once they reach the colon, converting the harmful environment into a beneficial trigger for colonization

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

2Reliability

If probiotic supplementation is administered to promote healthy intestinal homeostasis, then gastrointestinal health is improved, but the bacteria fail to compete with established microflora in the colon

Engineering Contradiction:

Improvecolonization abilityVSAvoidcompetition with established microflora

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent prepares the probiotic bacteria in advance by inducing spore formation before administration. This preliminary spore formation allows the bacteria to survive the gastrointestinal transit and reach the colon in a viable state, giving them a head start to compete with established microflora upon arrival

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent employs spore-forming bacteria that can preemptively resist the competitive pressure from established colon microflora. The spore form provides a protective advantage that allows these bacteria to withstand the competitive environment of the colon and establish colonization more effectively than conventional probiotics

Inventive Principle:

Principle #9Preliminary anti-action

3Ease of manufacture

If probiotic products are manufactured with standard food technology, then they can be produced and distributed, but storage and packaging conditions reduce probiotic stability

Engineering Contradiction:

Improvemanufacturing and distributionVSAvoidprobiotic stability

Core Design Contradiction:

Ease of manufactureVSStability of the object's composition

Solution Approach 1:

The patent changes the physical state of the probiotic from vegetative cells to spores, which have inherently greater stability. Spores can withstand a broader range of temperatures, pH levels, and oxygen conditions during storage and manufacturing processes, maintaining probiotic stability without requiring specialized storage conditions

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs spore-forming bacteria that can be produced as stable, shelf-ready products without requiring expensive cold chain storage or specialized packaging. The spores remain viable through standard manufacturing and distribution processes, eliminating the need for complex stability-maintaining infrastructure

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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 method effectively reduces episodes of constipation and diarrhea, maintains healthy gut microflora, and promotes regular bowel movements by enhancing the colonization and survival of beneficial bacteria in the gastrointestinal tract.

Implementation Method 1

utilizing its ability to form spores that protect against harsh conditions and promote colonization in the GI tract

Methodology Applied

Scientific EffectSpore formation:

Data Source

PatentUS12194142B2<i>Bacillus subtilis </i>containing composition for treatment of gastrointestinal irregularity

Publication Date: 2025.01.14 DEERLAND ENZYMES

AI summary

The present invention relates to methods of treating gastrointestinal irregularity, as well as promoting, maintaining, and restoring gastrointestinal regularity, and maintaining healthy gut microflora in an individual. The present invention relates to methods comprising orally administering to an individual a Bacillus subtilis composition wherein the individual's gastrointestinal irregularity is treated, and/or the individual's gastrointestinal regularity and/or healthy gut microflora is promoted, maintained, and/or restored.