Fecal Microbe Preparation for Gut Microbiota Modulation in Autism
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Solution Overview
Problem
Current treatments for autism spectrum disorder (ASD) lack effectiveness in reducing core symptoms, with no FDA-approved methods for alleviating the condition beyond managing irritability, highlighting a need for improved therapeutic approaches.
Innovation Solution
Microbiota Transfer Therapy (MTT) involves transferring beneficial fecal bacteria to rebalance the gut microbiota, selectively modulating the abundance of certain fecal microbes or bacteriophages to treat ASD patients, aiming to improve gastrointestinal and core ASD symptoms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional medications (risperidone, aripiprazole) are used to treat ASD, then irritability is reduced, but core symptoms of ASD remain untreated and no FDA-approved treatments exist for core symptom reduction
Solution Approach 1:
The patent changes the fundamental parameter of treatment approach from conventional pharmaceutical medications to fecal microbiota transfer therapy. This parameter change enables treatment of both core ASD symptoms and gastrointestinal comorbidities, expanding the scope of symptom coverage while maintaining treatment effectiveness through gut-brain axis modulation.
Solution Approach 2:
The patent introduces the gut microbiota as an intermediary mechanism between the gut and brain. By transferring beneficial fecal bacteria, the therapy modulates the gut-brain axis to simultaneously address core ASD symptoms and gastrointestinal issues, achieving versatile symptom coverage that conventional medications cannot accomplish.
2Reliability
If fecal microbiota transfer therapy is administered to ASD patients, then gastrointestinal symptoms and core ASD symptoms improve, but the treatment mechanism is not fully understood and requires selective modulation of specific microbes
Solution Approach 1:
The patent applies local quality by selectively targeting and modulating specific gut microbiota populations (increasing beneficial bacteria like Bifidobacterium, Prevotella, Desulfovibrio while reducing harmful ones). This localized microbial modulation achieves symptom improvement without requiring complex system-wide changes, simplifying the treatment mechanism while maintaining effectiveness.
Solution Approach 2:
The patent segments the complex gut microbiota into beneficial and harmful components, then selectively modulates each segment. By focusing on specific bacterial genera and their functions, the therapy achieves reliable symptom improvement while managing the complexity of microbiota modulation through targeted rather than comprehensive intervention.
3Quantity of substance
If beneficial fecal bacteria are transferred to rebalance gut microbiota, then abundance of beneficial bacteria increases, but the process requires identification and selection of appropriate donor microbiota
Solution Approach 1:
The patent implements feedback mechanisms to monitor changes in gut microbiota composition and clinical symptoms during and after therapy. This feedback enables identification of responders and optimization of donor selection criteria, making the complex task of donor microbiota identification more manageable while ensuring increased abundance of beneficial bacteria.
Solution Approach 2:
The patent establishes specific parameters for donor selection based on microbiota composition, diversity, and functional characteristics. By defining measurable criteria for acceptable donors, the therapy simplifies the complex task of donor identification while ensuring the transfer of beneficial bacteria that increase in abundance and produce therapeutic effects.
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 therapy demonstrates significant improvements in gastrointestinal and core ASD symptoms, with increased abundance of beneficial bacteria like Bifidobacterium, Prevotella, and Desulfovibrio, leading to reduced symptom severity and improved quality of life for ASD patients.
Implementation Method 1
administering a therapeutically effective amount of a pharmaceutical composition comprising a fecal microbe preparation to increase the abundance of one or more gut microorganisms
Implementation Method 2
treating the subject with an antibiotic to reduce the abundance of one or more gut microorganisms
Data Source
AI summary
The present disclosure relates to compositions and methods for treating autism spectrum disorder (ASD) by restoring an ASD patient's gut microbiota. These methods can be used with ASD patient with or without ongoing gastrointestinal symptoms. Provided here is a method for modulating the abundance of one or more gut microorganisms in a subject in need thereof, said method comprising administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising a fecal microbe preparation to achieve at least a 2-fold change of the abundance of said one or more fecal microorganisms, wherein said one or more gut microorganisms are selected from the group consisting of Bifidobacterium, Prevotella, Desulfovibrio, Copprococcus, Clostridium, and Bacteroides.