Compositions and Methods for Detecting and Treating Brain Injury Associated Fatigue and Altered Cognition (BIAFAC)

Abstract

The present invention includes composition, methods and kits for detecting and treating brain injury associated fatigue or altered cognition (BIAFAC) in a human patient comprising: identifying a human patient in need of treatment for brain injury associated fatigue or altered cognition associated with an altered intestinal flora; and providing the human patient with a composition comprising at least one of: a Prevotella spp or a Bacteroidies spp bacteria, or one or more agents that increase the amount of the Prevotella spp or the Bacteroidies spp bacteria in an intestinal flora of the human patient to reduce or eliminate the brain injury associated fatigue or altered cognition.

What is claimed is: 
     
         1 . A method of identifying a patient with a brain injury associated fatigue or altered cognition (BIAFAC) that will benefit from a probiotic bacteria treatment comprising:
 identifying a human patient with a brain injury associated fatigue or altered cognition;   obtaining a biological sample from the patient that comprises gut intestinal flora; and   determining whether the gut intestinal flora in the biological sample comprises a decrease in the presence of probiotic bacteria selected from at least one of  Prevotella  spp or  Bacteroidies  spp bacteria, when compared to a normal human sample.   
     
     
         2 . The method of  claim 1 , further comprising treating the patient with a composition comprising one or more probiotic bacteria selected from at least one of:  Prevotella  spp or  Bacteroidies  spp, or one or more agents that increase the amount of  Prevotella  spp or  Bacteroidies  spp in an intestinal flora of the patient, wherein a composition comprises an amount effective to reduce or eliminate the brain injury associated fatigue or altered cognition. 
     
     
         3 . The method of  claim 1 , further comprising providing the patient with a fecal transplant comprising  Prevotella  spp or  Bacteroidies  spp. 
     
     
         4 . The method of  claim 1 , wherein the biological sample is a fecal sample. 
     
     
         5 . The method of  claim 1 , wherein a presence of a probiotic bacteria is determined by at least one of metagenomic shotgun sequencing of bacteria, quantitative PCR assays or metabolic LC-MS analysis of bacterial metabolites. 
     
     
         6 . The method of  claim 1 , further comprising the step of providing the patient with an agent that reduces or eliminates  Ruminococcaceae  genus bacteria. 
     
     
         7 . The method of  claim 6 , wherein the agent that reduces or eliminates  Ruminococcaceae  genus bacteria is selected from an amino acid mixture, an antibacterial agent, a bacteriophage, or an antimicrobial CRISP-Cas system agent. 
     
     
         8 . The method of  claim 1 , wherein the human patient has brain injury that is chronic, mild, or undiagnosed, or is caused by stroke, hemorrhage, surgery, or radiation. 
     
     
         9 . The method of  claim 1 , wherein a composition is provided to the patient that further comprises an amino acid mixture that promotes a growth of  Prevotella  spp or  Bacteroidies  spp. 
     
     
         10 . The method of  claim 1 , wherein a composition is provided to the patient further comprises an amino acid mixture that reduces or eliminates  Ruminococcaceae  genus bacteria. 
     
     
         11 . The method of  claim 1 , wherein the patient did not receive a concurrent antibiotic or a probiotic therapy. 
     
     
         12 . The method of  claim 1 , wherein the one or more bacteria is listed in Tables 3, 4, 5 and 6. 
     
     
         13 . The method of  claim 1 , further comprising providing the human patient a bacterial composition that is modified to correct a TBI flora to a normal flora is provided before, during, or after undergoing a colon cleanse treatment, delivered by colonoscope, wherein the bacterial composition is not a fecal transplant, or wherein bacteria are lab-grown, or wherein bacteria are lab-grown and customized to specifically modify a TBI flora of a specific patient. 
     
     
         14 . A method of treating a human patient with a brain injury associated fatigue or altered cognition (BIAFAC) that will benefit from a probiotic bacteria treatment comprising:
 identifying a human patient with a brain injury associated fatigue or altered cognition;   obtaining a biological sample from the human patient that comprises gut intestinal flora; and   determining whether the gut intestinal flora in the biological sample comprises a decrease in the presence of probiotic bacteria selected from at least one of  Prevotella  spp or  Bacteroidies  spp bacteria, when compared to a normal human sample; and   providing the human patient with a composition comprising one or more probiotic bacteria selected from at least one of:  Prevotella  spp or  Bacteroidies  spp, in an effective amount sufficient to reduce or eliminate the brain injury associated fatigue or altered cognition.   
     
     
         15 . The method of  claim 14 , wherein the composition comprises one or more probiotic bacteria selected from at least one of:  Prevotella  spp or  Bacteroidies  spp, or one or more agents that increase the amount of  Prevotella  spp or  Bacteroidies  spp in an intestinal flora of the patient, wherein a composition comprises an amount effective to reduce or eliminate the brain injury associated fatigue or altered cognition. 
     
     
         16 . The method of  claim 14 , wherein the composition comprises a fecal transplant comprising  Prevotella  spp or  Bacteroidies  spp. 
     
     
         17 . The method of  claim 14 , wherein a presence of a probiotic bacteria is determined by at least one of metagenomic shotgun sequencing of bacteria, quantitative PCR assays or metabolic LC-MS analysis of bacterial metabolites. 
     
     
         18 . The method of  claim 14 , further comprising the step of providing the patient with an agent that reduces or eliminates  Ruminococcaceae  genus bacteria selected from an amino acid mixture, an antibacterial agent, a bacteriophage, or an antimicrobial CRISP-Cas system agent. 
     
     
         19 . The method of  claim 14 , wherein the human patient has brain injury that is chronic, mild, or undiagnosed, or is caused by stroke, hemorrhage, surgery, or radiation. 
     
     
         20 . The method of  claim 14 , wherein the composition is provided to the patient that further comprises an amino acid mixture that promotes a growth of  Prevotella  spp. or  Bacteroidies  spp., and an amino acid mixture that reduces or eliminates  Ruminococcaceae  genus bacteria. 
     
     
         21 . A method of treating brain injury associated fatigue or altered cognition (BIAFAC) in a human patient comprising:
 identifying a human patient in need of treatment for a brain injury associated fatigue or altered cognition associated with an altered intestinal flora; and   providing the human patient with a composition comprising at least one of: a  Prevotella  spp or a  Bacteroidies  spp bacteria, or one or more agents that increase an amount of the  Prevotella  spp or the  Bacteroidies  spp bacteria in an intestinal flora of the human patient to reduce or eliminate the brain injury associated fatigue or altered cognition.   
     
     
         22 . A blood test assay that determines a biological profile associated with a bacterial flora that exacerbates a brain injury associated fatigue or altered cognition for testing a fecal sample from a patient that compares the biological profile from the patient to a database of a normal biological profile, wherein the bacterial flora detected is selected from  Prevotella  spp,  Bacteroidies  sp, or  Ruminococcaceae  genus bacteria. 
     
     
         23 . A kit for screening a patient for a brain injury associated fatigue or altered cognition of a patient and choosing a proper treatment based on the screening, the kit comprising:
 a screening tool that screens the patient for a risk of brain injury associated fatigue or altered cognition, the screening tool comprising a questionnaire and further comprising a screening score system that determines the risk of the patient based on a cumulative point total from answers to the questionnaire;   a diagnostic test that categorizes the brain injury associated fatigue or altered cognition based on the cumulative point total from the questionnaire;   a fecal sample collection container for determining a bacterial flora in a fecal sample of the patient;   instructions for implementing the brain injury associated fatigue or altered cognition treatment; and   a brain injury associated fatigue or altered cognition treatment composition comprising one or more probiotic bacteria selected from at least one of:  Prevotella  spp or  Bacteroidies  spp, or one or more agents that increase the amount of  Prevotella  spp or  Bacteroidies  spp in an intestinal flora of the patient, wherein the composition comprises an amount effective to reduce or eliminate the brain injury associated fatigue or altered cognition.   
     
     
         24 . A method of diagnosing and treating a patient for brain injury associated fatigue or altered cognition, the method comprising:
 using an algorithm implemented in a computer program to: screen a patient for a brain injury associated fatigue or altered cognition risk by scoring a questionnaire based on answers from the patient to the questionnaire, the scoring providing a cumulative point total, and determining the brain injury associated fatigue or altered cognition of the patient based on the cumulative point total from the questionnaire; and   choosing a proper brain injury associated fatigue or altered cognition treatment product if the brain injury associated fatigue or altered cognition risk exceeds a threshold, the brain injury associated fatigue or altered cognition treatment product comprising a composition comprising one or more probiotic bacteria selected from at least one of:  Prevotella  spp or  Bacteroidies  spp, or one or more agents that increase the amount of  Prevotella  spp or  Bacteroidies  spp in an intestinal flora of the patient, wherein the composition comprises an amount effective to reduce or eliminate the brain injury associated fatigue or altered cognition.