Bacterial Metagenomic Stool Analysis for IBD Diagnosis

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Solution Overview

Problem

Current methods lack an effective way to diagnose inflammatory bowel diseases like ulcerative colitis and Crohn's disease, as the underlying causes are unclear, and existing diagnostic tests are not sufficient for early detection and differentiation between these conditions.

Innovation Solution

A method involving bacterial metagenomic analysis of stool samples using PCR with specific primers to compare the content of bacteria and bacteria-derived vesicles between subject and normal samples, identifying specific phyla, classes, orders, families, and genera associated with these diseases.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If endoscopy is used for diagnosing inflammatory bowel disease, then information necessary for diagnosis and differentiation is provided, but the method is invasive and cannot detect early-stage changes

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidinvasiveness
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent uses bacteria-derived extracellular vesicles as intermediary carriers to transfer bacterial genetic material across the intestinal mucosal barrier. These vesicles naturally penetrate the barrier and deliver bacterial DNA to host cells, enabling non-invasive detection of pathogenic bacteria through stool samples while maintaining diagnostic accuracy

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces the mechanical invasive procedure of endoscopy with a molecular biology approach using metagenomic sequencing. Instead of physically visualizing the intestinal lining, the method sequences bacterial DNA from stool samples to identify pathogenic organisms, eliminating procedural risks while preserving diagnostic capability

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Loss of time

If metagenomic analysis is performed on stool samples, then non-invasive early detection is achieved, but the complexity of analyzing bacterial composition increases

Engineering Contradiction:
Improveearly detection capabilityVSAvoidanalysis complexity
Core Design Contradiction:
Loss of timeVSDevice complexity

Solution Approach 1:

The patent extracts and isolates bacteria-derived extracellular vesicles from stool samples before performing metagenomic analysis. This extraction step concentrates the relevant bacterial genetic material and removes interfering substances, simplifying subsequent sequencing and analysis while enabling early detection of pathogenic bacteria

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent segments the complex stool sample into distinct components by isolating extracellular vesicles containing bacterial DNA. This segmentation separates the diagnostic signal (bacterial genetic material in vesicles) from the background noise (other stool components), making the metagenomic analysis more manageable and interpretable

Inventive Principle:
Principle #1Segmentation

3Loss of information

If bacteria are isolated and analyzed, then causative factors of inflammatory bowel disease are identified, but the method cannot distinguish between different types of inflammatory bowel disease

Engineering Contradiction:
Improveidentification of causative factorsVSAvoiddifferential diagnosis capability
Core Design Contradiction:
Loss of informationVSAdaptability or versatility

Solution Approach 1:

The patent analyzes the composition and characteristics of extracellular vesicles at different levels (phylum, class, order, family, genus) to identify specific patterns associated with different types of inflammatory bowel disease. This multi-level analysis provides localized diagnostic information that enables differentiation between ulcerative colitis and Crohn's disease based on distinct bacterial signatures

Inventive Principle:
Principle #3Local quality

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

This approach enables early prediction and diagnosis of inflammatory bowel diseases, potentially delaying or preventing their onset and improving treatment outcomes by identifying causative factors and serving as a marker for differential diagnosis.

Implementation Method 1

performing polymerase chain reaction (PCR) on the extracted DNA using a pair of primers

Methodology Applied
Scientific EffectPolymerase Chain Reaction (PCR):

Data Source

PatentUS12084721B2Inflammatory bowel disease diagnostic method by means of bacterial metagenomic analysis
Publication Date: 2024.09.10 MD HEALTHCARE INC
  • US12084721B2 patent drawing
  • US12084721B2 patent drawing
  • US12084721B2 patent drawing

AI summary

The present invention relates to a method for prognosing the occurrence and the causative factor of an inflammatory bowel disease such as ulcerative colitis and Crohn's disease by means of a metagenomic analysis of bacterial and bacterial-derived vesicles present in a human body-derived substance and, more particularly, to a method for diagnosing the causative factor and occurrence risk of an inflammatory bowel disease by analyzing a metagenomic sequence present in bacteria and bacteria-derived vesicles present in stool. Trillions of bacteria are present in the intestine, and vesicles are secreted outside the cells for exchange of information. Bacterial are not absorbed into the intestinal epithelial cells, but the vesicles secreted from the bacteria pass through the mucous, are absorbed into the intestinal epithelial cells and can increase or reduce inflammation. The present invention can be facilitated as a method for diagnosing the occurrence risk and causative factor of an inflammatory bowel disease by means of a gene metagenomic sequence analysis of bacteria and bacterial=-derived vesicles present in a human body-derived substance. Also, the present invention enables early diagnosis even after an occurrence of an inflammatory bowel disease, reduces the occurrence of an inflammatory bowel disease, and can enhance therapeutic effects.