Sterilized Fecal-Derived Prebiotic Composition for Live-Microbe-Free Therapy
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Solution Overview
Problem
Large scale clinical research on non-sterilized fecal microbiota transplant (FMT) is lacking due to financial burden and speed, despite its efficacy in treating Clostridioides difficile infections, necessitating a safer and more controlled method for fecal-derived prebiotic and postbiotic compositions.
Innovation Solution
A method for producing a fecal-derived sterilized prebiotic and postbiotic composition involves collecting a stool sample from a healthy donor, freezing it, sterilizing it, blending with a liquid, and stabilizing through lyophilization to create a composition comprising short chain fatty acids and biological macromolecules, which can be administered orally, intranasally, vaginally, or rectally in various forms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If non-sterilized FMT is used to treat Clostridioides difficile infections, then treatment efficacy is improved, but safety risks and financial burden increase
Solution Approach 1:
The patent extracts and isolates specific beneficial components (short chain fatty acids and biological macromolecules) from the complex FMT mixture, creating a purified composition that maintains therapeutic efficacy while eliminating safety risks associated with live organisms and contaminants
Solution Approach 2:
The patent converts the harmful aspect of non-sterilized FMT (presence of live organisms and potential contaminants) into a benefit by using sterilization to eliminate risks while preserving and concentrating the beneficial metabolic products, thereby transforming a dangerous approach into a safe one
2Productivity
If non-sterilized FMT is introduced quickly, then treatment availability is improved, but large scale clinical research is hindered
Solution Approach 1:
The patent creates a stable, shelf-ready sterilized composition that can be stored and distributed without immediate processing, enabling widespread availability while maintaining consistent quality for clinical research through standardized manufacturing
3Object-affected harmful factors
If sterilization is applied to FMT, then safety is improved, but presence of live organisms is reduced
Solution Approach 1:
The patent extracts the beneficial metabolic products (short chain fatty acids and biological macromolecules) from the live microbial community, creating a therapy that delivers therapeutic effects without requiring live organisms, thus ensuring safety while maintaining quantity of active substances
Solution Approach 2:
The patent creates a simplified copy or representation of the beneficial effects of live FMT by isolating and delivering the key metabolic products (SCFAs and macromolecules) without the complex live microbial ecosystem, achieving similar therapeutic outcomes with enhanced safety
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 sterilized composition ensures the absence of live organisms while maintaining beneficial biological macromolecules, providing a safe and effective treatment for gastrointestinal health and immune system modulation, with increased concentrations of key molecules like short chain fatty acids and bile acids.
Implementation Method 1
sterilizing the stool sample
Implementation Method 2
stabilizing the fecal-derived composition by lyophilization
Implementation Method 3
wherein the stool sample is frozen
Data Source
AI summary
Methods and compositions relating to sterilized fecal microbiota and compositions derived from the same. A method of sterilizing a fecal composition to obtain a sterilized fecal composition is provided. Methods of further purifying the sterilized composition and optionally freezing or freeze-drying the compositions is also provided. Methods of using the compositions for treatment in beverages, foods, and in supplements are also provided.