Fecal Microbe Preparation for Modulating ASD Metabolite Levels
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Solution Overview
Problem
Current treatments for Autism Spectrum Disorder (ASD) are limited, with no FDA-approved methods for reducing or eliminating core symptoms, and existing medications only address irritability, highlighting a need for improved therapeutic approaches.
Innovation Solution
Administration of a pharmaceutical composition comprising a fecal microbe preparation to alter the levels of specific fecal and plasma metabolites, including amino acid, fatty acid, and bile acid metabolites, to treat ASD symptoms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If FDA-approved medications (risperidone, aripiprazole) are used to treat ASD, then irritability symptoms are reduced, but core symptoms of autism spectrum disorder cannot be addressed
Solution Approach 1:
The patent changes the therapeutic approach from pharmacological intervention to microbiota-based intervention. By administering fecal microbe preparations, the invention modifies gut microbiome composition, which in turn affects metabolite levels (such as p-cresol sulfate, oxalate, isocaproate) that are implicated in ASD pathophysiology. This parameter change from direct CNS-acting medications to gut-microbiome-metabolite pathway modulation enables treatment of core ASD symptoms beyond just irritability.
2Adaptability or versatility
If no treatment is administered, then core symptoms of ASD remain untreated, but existing treatments only address irritability and not other neurological or gastrointestinal comorbidities
Solution Approach 1:
The fecal microbe preparation serves multiple therapeutic functions simultaneously. By modulating gut microbiota, it addresses neurological symptoms (social interaction, communication, repetitive behaviors), gastrointestinal comorbidities (constipation, diarrhea, gastroesophageal reflux), and metabolic abnormalities (elevated p-cresol sulfate, oxalate, isocaproate). This multi-functional approach makes the treatment versatile across different ASD manifestations while maintaining reliable symptom reduction through microbiome-mediated metabolic correction.
3Manufacturing precision
If fecal microbe preparation is administered to alter metabolite levels, then targeted metabolites are reduced or increased, but the mechanism by which this alleviates ASD symptoms requires further validation
Solution Approach 1:
The patent employs a feedback mechanism where fecal microbe preparations are administered to modulate specific metabolite levels (p-cresol sulfate, oxalate, isocaproate, 1-(1-enyl-palmitoyl)-GPE(P-16:0)), and the therapeutic effect is monitored through clinical assessment of ASD symptoms and metabolite level measurement. The microbiota-metabolite- symptom relationship creates a feedback loop where metabolite changes serve as biomarkers for treatment response, allowing adjustment and optimization of the therapeutic approach while building evidence for the mechanism of action.
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 effectively reduces or increases targeted metabolites, potentially alleviating ASD symptoms by modifying gut microbiota, as demonstrated by improvements in gastrointestinal symptoms and autism rating scales.
Implementation Method 1
The fecal microbe preparation modifies gut microbiota, as demonstrated by improvements in gastrointestinal symptoms and autism rating scales
Implementation Method 2
Administration of a pharmaceutical composition comprising a fecal microbe preparation to alter the levels of specific fecal and plasma metabolites, including amino acid, fatty acid, and bile acid metabolites
Data Source
AI summary
The present disclosure relates to methods and compositions suitable for changing metabolite levels in a subject in need thereof. In particular, this application provides methods and compositions for changing metabolite levels in a subject diagnosed with Autism Spectrum Disorder (ASD). Methods of preventing or treating an ASD in a subject thereof, as well as methods of selecting a treatment plan for treating an ASD in a subject are also provided.