Method of diagnosis and treating gastrointestinal and neurological diseases associated with species of genus Clostridium
Inventors
Finegold, Sydney M. • Carlson, Paula
Assignees
US Department of Veterans Affairs
Publication Number
US-11174521-B2
Publication Date
2021-11-16
Expiration Date
2037-07-03
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Abstract
The invention includes a method of diagnosis and treating autism associated with an overgrowth of beta2-toxin-gene-positive Clostridium perfringens in the gut of an autistic subject. In one embodiment, the method comprises administering to the subject (e.g. a subject having an overgrowth of beta2-toxin-gene-positive Clostridium perfringens in the gut) one or more agents to reduce or eliminate beta2-toxin-gene positive Clostridium perfringens in the subject so as to relieve one or more symptoms of autism.
Core Innovation
The invention provides a method for diagnosing and treating autism associated with an overgrowth of beta2-toxin-gene-positive Clostridium perfringens in the gut of an autistic subject. The method involves administering one or more agents to reduce or eliminate the beta2-toxin-gene-positive Clostridium perfringens, thereby relieving one or more symptoms of autism such as social deficits, language impairment, repetitive behaviors, and associated neurological issues.
The problem being addressed is the higher incidence and overgrowth of clostridia, specifically beta2-toxin-gene-positive Clostridium perfringens, found in the intestinal microflora of autistic children compared to non-autistic subjects. This overgrowth correlates with reduced bacterial diversity and contributes to the clinical picture of autism. The invention targets these toxin-producing organisms as a novel approach for diagnosis and treatment.
Claims Coverage
The claims include one independent claim centered on a method for reducing beta2-toxin-gene-positive Clostridium perfringens in the gut of autistic subjects using an anti-toxin, with various dependent features specifying patient characteristics and details of the bacteria and treatment.
Administering an anti-toxin to reduce beta2-toxin-positive Clostridium perfringens levels
The method involves administering to an autistic subject an anti-toxin specific to Clostridium perfringens beta2-toxin gene in an amount effective to reduce the beta2-toxin-gene-positive Clostridium perfringens in the gut, with treatment efficacy measured by a reduction in colony forming units in fecal samples.
Characterization of beta2-toxin-gene-positive Clostridium perfringens in fecal samples
The claims specify the presence of more than about 1.5×103 colony forming units per gram dry weight of beta2-toxin-gene-positive Clostridium perfringens before administration and detailed genetic characteristics of the bacteria, including presence or absence of alpha-toxin and other toxin genes.
Targeted treatment of different autism onset types and age groups
The method is applicable to autistic subjects with early onset autism, late onset autism, or regressive autism, particularly children less than 12 years old or 3 years or younger.
Detection and monitoring using specific primer pairs
The presence of beta2-toxin-gene-positive Clostridium perfringens is detected by a primer pair directed to sense and antisense strands of the gene for diagnosis and possibly monitoring treatment efficacy.
Combination treatment with probiotics
The method may further include administering a probiotic alongside the anti-toxin treatment to aid in restoring gut flora balance.
Overall, the independent claims focus on diagnosis based on beta2-toxin-gene-positive Clostridium perfringens levels and applying targeted anti-toxin treatments to reduce these bacterial levels in autistic subjects to alleviate autism symptoms, with specifics on bacterial genetics, patient age, autism type, detection methods, and adjunct probiotic use.
Stated Advantages
Targets beta2-toxin-gene-positive Clostridium perfringens specifically, aiming to relieve one or more symptoms of autism.
Allows for diagnosis and monitoring of autism-associated bacterial overgrowth using fecal samples.
Enables treatment tailored to pediatric patients, including very young children with various forms of autism.
Potential for combination therapy including anti-toxins and probiotics to restore healthy gut flora.
Documented Applications
Diagnosing overgrowth of beta2-toxin-gene-positive Clostridium perfringens in gut microbiota of autistic children using fecal specimens.
Treating autism-associated symptoms by reducing or eliminating beta2-toxin-gene-positive Clostridium perfringens via administration of antimicrobial agents, antibodies (anti-toxins), probiotics, bacteriophages, prebiotics, or vaccines.
Monitoring the course and severity of autism by quantifying bacterial overgrowth or toxin activity in biological samples over time.
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