Processed Donor Fecal Samples for Standardized C. difficile Bacteriotherapy
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Solution Overview
Problem
Clostridium difficile overpopulation in the gastrointestinal tract leads to severe health issues, with traditional antibiotic treatments showing high recurrence rates and significant financial and mortality impacts, and existing fecal bacteriotherapy methods lack standardized, hygienic, and efficient delivery systems.
Innovation Solution
A bacteriotherapy product comprising a processed donor fecal sample with a cryoprotectant, homogenized and filtered, is packaged in oral tablets, capsules, or ampules for antegrade/retrograde gastrointestinal delivery, utilizing a bacteriotherapy bank to store and index donor samples for personalized treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional antibiotic treatments are used to clear normal intestinal flora, then clostridium difficile spores become resistant and overgrow, but this approach fails to effectively treat the infection and leads to high recurrence rates
Solution Approach 1:
The patent converts the harmful effect of antibiotic-resistant clostridium difficile spores into a beneficial treatment by using fecal bacteriotherapy. The donor fecal sample contains beneficial bacteria that outcompete and displace the pathogenic clostridium difficile, transforming the problem of antibiotic resistance into an opportunity for microbiota-based therapy that restores healthy gut flora balance without relying on antibiotics.
Solution Approach 2:
The patent introduces a mediator (donor fecal sample containing beneficial bacteria) to resolve the conflict between antibiotic treatment and clostridium difficile overgrowth. This intermediary microbiota acts as a biological agent that competes with pathogenic bacteria for resources and attachment sites, thereby treating the infection without directly confronting the resistant spores with additional antibiotics.
2Reliability
If fecal bacteriotherapy is used to displace pathogenic organisms, then treatment effectiveness improves, but lack of standardized delivery systems reduces hygiene and efficiency
Solution Approach 1:
The patent segments the fecal sample into controlled portions and encapsulates them in standardized delivery systems (capsules or ampules). This segmentation allows for precise dosing, controlled release, and standardized administration protocols, transforming the unstandardized fecal transplant procedure into a reproducible, hygienic, and efficient medical treatment with consistent quality control.
Solution Approach 2:
The patent changes the physical and chemical parameters of the fecal sample by processing it through homogenization, filtration, and encapsulation. These parameter changes transform the raw fecal material into a standardized, stable, and easy-to-administer formulation that maintains bacterial viability while ensuring hygiene and consistency across different treatments.
3Ease of operation
If fecal samples are processed and stored for bacteriotherapy, then treatment convenience improves, but storage conditions must be maintained to preserve bacterial viability
Solution Approach 1:
The patent performs preliminary actions by processing and cryopreserving the fecal sample in advance of treatment. The sample is homogenized, filtered, encapsulated with cryoprotectants, and stored at ultra-low temperatures before administration. This preliminary preparation ensures bacterial viability is preserved during storage and transport, while the standardized format provides treatment convenience when needed.
Solution Approach 2:
The patent utilizes phase transitions by cryopreserving the fecal sample at ultra-low temperatures (typically -80°C or lower) to maintain bacterial viability during storage. The cryoprotectants prevent ice crystal formation that would damage bacterial cells during freezing. When treatment is needed, the sample is thawed and administered, completing the phase transition from frozen to liquid state while preserving bacterial functionality.
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
Provides a convenient, hygienic, and effective method to displace pathogenic organisms with healthy flora, reducing recurrence rates and hospital stays, while minimizing exposure risks and costs.
Implementation Method 1
a cryoprotectant added to the donor fecal sample
Data Source
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AI summary
This document discusses, among other things, receiving a plurality of donor fecal samples from a plurality of donors and storing and indexing each respective donor fecal samples using at least one characteristic of the respective donor fecal sample. In an example, the donor fecal sample can be screened and processed for subsequent use in fecal bacteriotherapy to displace pathogenic or undesired organisms in the digestive track of a patient with healthy or desirable gut micriobiota.