Immunomodulatory Composition Using Non-Culturable Bacteria
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Solution Overview
Problem
Current immunomodulatory compositions fail to effectively utilize the high microbial diversity found in natural environments, particularly due to the spatial and temporal heterogeneity of non-culturable bacterial communities, which are difficult to enrich and often contain pathogenic species, limiting their efficacy in modulating the gut microbiome and immune system.
Innovation Solution
Development of an immunomodulatory composition comprising a microbial community with a Shannon diversity index of at least 3, operational taxonomic units (OTUs) richness of at least 130, and bacterial 16S copies per gram of 1,000,000, while maintaining pathogen levels similar to those found in everyday environments, using natural materials that retain non-culturable bacteria and their active components to induce a beneficial IL-10-mediated immunoregulatory response.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If non-culturable bacterial communities are utilized to increase microbial diversity, then the immunomodulatory efficacy is improved, but the spatial and temporal heterogeneity and difficulty of enrichment worsen the manufacturing and standardization process
Solution Approach 1:
The patent segments the complex non-culturable bacterial community into a defined composition with minimum diversity requirements (Shannon index ≥3, ≥130 OTUs, ≥1,000,000 bacterial copies/g). This segmentation transforms the unmanageable heterogeneity into standardized, measurable parameters that can be consistently manufactured and quality-controlled.
Solution Approach 2:
The patent changes the approach from attempting to control the entire complex community to instead defining and controlling key parameters (diversity index, OTU richness, bacterial abundance, pathogen levels). This parameter-based control enables standardization while preserving the beneficial microbial diversity.
2Reliability
If cultivated probiotic strains are used to ensure safety and controllability, then pathogen risk is reduced, but the microbial diversity and immunomodulatory efficacy are limited
Solution Approach 1:
The patent introduces processed natural material as an intermediary that bridges the gap between cultivated probiotics and raw environmental samples. The material is processed to reduce pathogens while preserving non-culturable bacteria, achieving both safety and diversity. The processing steps (composting, drying, sieving) act as intermediaries that transform raw material into a safe, diverse composition.
Solution Approach 2:
The patent creates a composite material that combines elements of natural environmental microbiota with processed safety controls. The final composition is a composite of non-culturable bacteria from natural sources, processed to eliminate pathogens while maintaining microbial diversity, thus achieving both safety and versatility.
3Adaptability or versatility
If human excretions (fecal matter) are used for microbiome transplantation, then high microbial diversity is achieved, but pathogen transmission risk increases
Solution Approach 1:
The patent converts the harmful aspect of raw fecal matter (pathogen risk) into a benefit by using it as a source of diverse non-culturable bacteria, then applying processing steps to eliminate pathogens. The harmful raw material is transformed into a beneficial safe composition through controlled processing that preserves microbial diversity while removing pathogens.
Solution Approach 2:
The patent extracts the beneficial non-culturable bacteria from the harmful fecal matrix through processing steps (composting, drying, sieving). This extraction separates the useful microbial diversity from the pathogenic components, achieving both safety and diversity in the final composition.
4Ease of manufacture
If single bacterial strains are used to ensure manufacturing simplicity, then ease of manufacture is improved, but the immunomodulatory effect on gut microbiome is insufficient
Solution Approach 1:
Instead of using a single strain (minimum action), the patent applies partial action by defining minimum thresholds for multiple parameters (Shannon index ≥3, ≥130 OTUs, ≥1,000,000 copies/g). This partial specification of multiple parameters achieves sufficient immunomodulatory efficacy without requiring complete control of the entire microbial community, balancing manufacturing feasibility with therapeutic effectiveness.
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 composition successfully increases microbial diversity, richness, and abundance, inducing a robust IL-10 immunoregulatory response without inflammation, effectively preventing or treating immune-related disorders by mimicking the microbial profile of low-risk subjects, such as traditional hunter-gatherers, and enhancing immune system efficiency.
Implementation Method 1
inducing a beneficial IL-10-mediated immunoregulatory response
Data Source
AI summary
The invention discloses an immunomodulatory composition comprising non-culturable bacteria, a method of production and an article and an apparatus for its use and administration.