Fecal Microbiota Homogenization for Bacterial Viability
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Solution Overview
Problem
Current fecal microbiota transplantation methods lack reproducibility and homogeneity, leading to variability in bacterial diversity and viability, which is crucial for effective treatment of intestinal dysbiosis and associated pathologies.
Innovation Solution
A method involving the collection of fecal microbiota samples from preselected donors, followed by oxygen-tight storage, qualitative control, addition of a cryoprotective agent, filtration, pooling, and homogenization to create a homogeneous mixture with high bacterial diversity and viability, ensuring intra-batch and inter-batch homogeneity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If fecal microbiota samples are collected and processed using current empirical methods, then the procedure is simple and quick, but the bacterial diversity and viability are insufficient and variable
Solution Approach 1:
The processing procedure is divided into distinct sequential steps: sample collection, qualitative control, addition of cryoprotective agent, filtration, pooling, and homogenization. Each step serves a specific function to preserve bacterial diversity and viability, transforming the empirical one-step approach into a systematic multi-stage process that ensures reliability.
Solution Approach 2:
The method implements preliminary actions by collecting samples from preselected donors meeting specific criteria before processing, and by adding cryoprotective agents immediately within 5 minutes of collection. These preliminary measures prevent degradation of bacterial diversity and viability before the main processing occurs.
2Manufacturing precision
If fecal microbiota samples are processed without strict quality control, then the procedure is faster and simpler, but homogeneity between batches varies significantly
Solution Approach 1:
The method incorporates qualitative control at multiple stages with defined exclusion criteria for samples that do not meet standards. This feedback mechanism ensures only qualifying samples proceed to pooling and homogenization, guaranteeing batch homogeneity while maintaining efficient processing by avoiding rework of不合格 samples.
Solution Approach 2:
The method standardizes processing parameters including the addition of cryoprotective agents within 5 minutes of collection, specific filtration steps, and controlled homogenization. These standardized parameter changes ensure consistent results across batches while maintaining reasonable processing times through optimized parameters.
3Reliability
If fecal microbiota samples are not preserved with cryoprotective agents, then the processing is simpler and faster, but bacterial viability decreases significantly
Solution Approach 1:
Cryoprotective agents are added within 5 minutes of sample collection as a preliminary action before filtration and pooling. This timing is critical to preserve bacterial viability while minimizing the added complexity, as the agent is simply mixed with the sample in a controlled manner.
Solution Approach 2:
Cryoprotective agents act as intermediaries between the fecal sample and the final processed product. These agents protect the bacteria during processing and storage, maintaining viability without requiring complex preservation systems, thus balancing reliability with ease of manufacture.
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 produces fecal microbiota samples with high bacterial diversity and viability, ensuring consistent treatment efficacy for conditions like graft-versus-host disease, Clostridium difficile infection, and inflammatory bowel disease, by maintaining bacterial stability and homogeneity throughout the process.
Implementation Method 1
adding to each of the samples retained after control step c) an aqueous saline solution comprising at least one cryoprotective agent and/or a bulking agent
Implementation Method 2
filtering the samples obtained at the end of step d) to form a series of inocula
Implementation Method 3
homogenizing said mixture obtained in step f), in particular by manual stirring or using a stirring device
Data Source
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AI summary
The present invention relates to a method for preparing a homogeneous mixture of fecal microbiota from at least two preselected donors. The homogeneous mixture of fecal microbiota thus obtained has a bacterial diversity and an increased viability. The homogeneous mixture of fecal microbiota may be used for treating intestinal dysbiosis and for treating pathologies associated with such dysbiosis.