From: logon23x@gmail.com   
      
   October 14, 2015   
      
   Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences –   
   Part III, Psychobiotics   
      
      
   [authors: Jessica Miles* and Anthony D. Sabatelli**]   
      
   This is the third article in a series on advancements in microbiome research   
   and development.  This installment reviews the area of microbiome research   
   known as the "gut-brain-axis" and therapies related thereto, which have been   
   dubbed "pyschobiotics."    
   Upcoming articles will continue to review important topics in this technology   
   area, and patents of interest.   
      
   Research into the microbiome focuses heavily on bacteria living in the gut,   
   which houses more bacteria than any other organ.  These bacteria are being   
   studied not only because they play a role in gastrointestinal disorzers like   
   Inflammatory Bowel Disease    
   (IBD), Crohn's Disease, and colorectal cancer, but also because they can   
   influence diverse and distal organs.  The gut-brain-axis -- the term for the   
   neurochemical pathway between the intestine and the brain -- is a prominent   
   example of such a    
   relationship.  As the research is starting to progress in this area, we are   
   also beginning to see patents relating to this area.   
      
   The gut-brain-axis and "psychobiotics"   
      
   The gut-brain-axis begins with the enteric nervous system (ENS), a network of   
   neurons that runs through the gastrointestinal tract.  From there, the gut   
   communicates with the brain via the vagus nerve, which connects the ENS to the   
   central nervous system,   
    transmitting signals up the spinal cord and to the brain.  However, the link   
   between bowel and brain is bidirectional, as the brain controls the immune   
   system and other autonomic functions that shape the bacterial populations   
   living in the gut.   
      
   The gut microbiota shapes brain function by promoting the synthesis of   
   neurochemicals that directly interact with the ENS.  The trillions of microbes   
   living in the human intestine produce a multitude of chemicals, called   
   metabolites.  Some metabolites    
   are the byproducts of bacterial fermentation of dietary fiber; one of these,   
   butyrate, influences brain function by regulating neuronal gene expression.    
   Others modulate critically important neuroendocrine molecules.  For example,   
   work published earlier    
   this year demonstrates that specific gut microbiome members interact with   
   intestinal cells to stimulate serotonin production, indicating that these   
   bacteria play a principle role in regulating the body's reservoir of this   
   important neurotransmitter and    
   mood-regulator.  Additional recent and emerging research implicates gut   
   bacteria in the production of such well-known neurotransmitters as dopamine,   
   gamma-Aminobutyric acid (GABA), histamine, noradrenaline, and adrenaline.   
      
   Underlining the connection between the brain and the gut, patients with   
   neurological and psychiatric disorders such as depression, anxiety, autism,   
   and childhood hyperactivity often present with gastrointestinal illness.    
   Because of this connection, and    
   the fact that the intestine is the main site of synthesis for many of these   
   psychoactive compounds, beneficial bacteria with potential psychiatric and   
   neurological effects are being called "psychobiotics."   
      
   Current State of R&D   
      
   A watershed moment for psychobiotics came in 2013, when researchers at UCLA   
   provided some of the earliest evidence that gut bacteria can alter human brain   
   function and mood.  This work came after several papers reported that   
   probiotic strains could    
   reduce depression- and anxiety-like behaviors in mice.  Since then, there has   
   been interest in understanding the interplay between bacteria and mood   
   disorders and how pyschobiotics might be used to improve brain development and   
   lessen behavioral symptoms    
   associated with conditions such as autism.  Notably, one of the first patents   
   relating to this area of research was issued earlier this year.  U.S. Patent   
   No. 8,927,242 (reviewed in detail in the previous installment) generally   
   relates to a bacterial    
   therapy for treatment of a subset of psychiatric disorders in children, called   
   PANDAS.  This patent was granted to NuBiome, a California-based company   
   specializing in treatments for autoimmune disorders.   
      
   There are also several patents pending for psychobiotic-based treatments.    
   Symbiotix cofounder Sarkis Mazmanian has filed for two patent applications in   
   this area of research: one relates to the use of bacterial probiotics for the   
   treatment of anxiety,    
   autism, and autism spectrum disorder, while the other relates to other   
   therapies, including fecal transplantation, to treat these disorders.  Autism   
   researcher Sydney Finegold has also filed two patent applications, both   
   relating to the use of    
   antimicrobials and probiotics to treat behavorial disorders.  Another   
   application, US 20140301995, generally relates to manipulating bifidobacteria   
   and clostridia in the gut to improve serotonin levels.  US 20150152484 covers   
   the characterization of    
   Prevotella, Coprococcus, Prevotellaceae, or Veillonellaceae bacteria in ASD   
   patients.  US 20150259728, which was filed in March, describes a treatment of   
   anxiety-like behavior and stress-induced inflammation in children.  The   
   treatment is a prebiotic:  a    
   non-digestible carbohydrate that stimulates growth of the gut microbiota.   
      
   Closing   
      
   The gut-brain-axis represents an exciting frontier for microbiome studies.    
   Despite their infancy, psychobiotics hold great promise for difficult-to-treat   
   mood and psychiatric disorders.  Although current patent and commercialization   
   activity in this    
   research area is low, this activity will increase as research this field   
   continues to grow.   
      
   * Jessica Miles is a Technology Specialist at Dilworth IP   
   ** Dr. Sabatelli is a Partner with Dilworth IP   
      
   For additional information regarding this topic, please see:   
      
   • "Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences   
   – Part II, 2015 Patent Trends," August 11, 2015   
   • "Guest Post -- The Emergent Microbiome: A Revolution for the Life Sciences   
   – Part I, R&D Leaders," August 10, 2015   
      
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