Purified Bacterial Mixture for Microbiome Colonization
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Solution Overview
Problem
Current methods fail to effectively colonize the microbiome with specific bacterial strains to treat inflammatory bowel disease (IBD) and graft versus host disease (GvHD), and there is a need for a pharmaceutical composition that can modulate the gut microbiota to reduce primary bile acids and increase secondary bile acids and short-chain fatty acids.
Innovation Solution
A pharmaceutical composition comprising a purified bacterial mixture of 2-16 strains, including Clostridium saccharogumia, Flavonifractor plautii, and Lachnospiraceae bacteria, administered orally or rectally, which colonizes the microbiome, reducing primary bile acids and increasing secondary bile acids and short-chain fatty acids, potentially treating IBD and GvHD.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a purified bacterial mixture comprising specific Clostridium and Lachnospiraceae strains is administered, then colonization of the microbiome is achieved and primary bile acids are reduced, but the complexity of the pharmaceutical composition and manufacturing process increases
Solution Approach 1:
The patent divides the microbiome modulation task into specific functional segments by selecting particular bacterial strains (Clostridium saccharogumia, Clostridium hathewayi, Clostridium bolteae, Clostridium indolis, and Lachnospiraceae bacteria) that each contribute to reducing primary bile acids. This segmentation allows for targeted therapy while maintaining manageable composition complexity through careful strain selection rather than using entire microbiota.
Solution Approach 2:
The patent changes the chemical parameters of the gut environment by introducing bacteria that specifically convert primary bile acids into secondary bile acids and short-chain fatty acids. This parameter change (reducing primary bile acid concentration by specific fold levels) achieves therapeutic effect while the defined bacterial mixture keeps the composition complexity controlled through standardized strain combinations.
2Reliability
If multiple bacterial strains are used to modulate gut microbiota, then therapeutic benefits for IBD and GvHD are achieved, but the difficulty of detecting and measuring colonization increases
Solution Approach 1:
The patent applies local quality by focusing detection efforts on specific functional markers rather than attempting to detect all bacterial strains individually. The presence of the bacterial mixture is measured through its functional output (reduction of primary bile acids, increase in secondary bile acids and short-chain fatty acids) rather than through complex multi-strain detection, simplifying the measurement process while maintaining therapeutic reliability.
3Reliability
If a defined bacterial mixture is administered to reduce primary bile acids, then the fold-reduction in primary bile acids increases, but the loss of time for colonization establishment increases
Solution Approach 1:
The patent applies preliminary action by pre-assembling the optimal combination of bacterial strains (Clostridium saccharogumia, Clostridium hathewayi, Clostridium bolteae, Clostridium indolis, and Lachnospiraceae bacteria) in a defined ratio before administration. This preliminary preparation ensures that upon administration, the bacteria can immediately begin colonizing and reducing primary bile acids without requiring extended establishment periods, thus achieving high fold-reduction while minimizing time loss.
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 effectively colonizes the microbiome, reducing primary bile acids by 2-fold to 100,000-fold and increasing secondary bile acids and short-chain fatty acids by 2-fold to 100,000-fold, providing therapeutic benefits for IBD and GvHD.
Implementation Method 1
each of the bacterial strains of the pharmaceutical composition colonizes the microbiome
Implementation Method 2
reducing primary bile acids by 2-fold to 100,000-fold
Implementation Method 3
increasing secondary bile acids by 2-fold to 100,000-fold
Implementation Method 4
increasing short-chain fatty acids by 2-fold to 100,000-fold
Data Source
AI summary
The disclosure relates to methods for colonizing a microbiome, by administering pharmaceutical compositions comprising a purified bacterial mixture to the subject. Also provided are methods for treating and/or preventing inflammatory bowel disease, methods for reducing the risk of inflammatory bowel disease and/or reducing the occurrence of inflammatory bowel disease in a subject by administering pharmaceutical compositions comprising a purified bacterial mixture to the subject. Also provided are methods for treating and/or preventing graft versus host disease in a subject by administering pharmaceutical compositions comprising a purified bacterial mixture to the subject.