<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262870</url>
  </required_header>
  <id_info>
    <org_study_id>GMAMS</org_study_id>
    <nct_id>NCT03262870</nct_id>
  </id_info>
  <brief_title>Gut Microbiota and Multiple Sclerosis</brief_title>
  <official_title>Gut Microbiota and Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gut microbiota and multiple sclerosis Multiple sclerosis is a pro-inflammatory demyelinating&#xD;
      disease of the central nervous system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple sclerosis is a pro-inflammatory demyelinating disease of the central nervous system.&#xD;
      The etiology of MS is complex and poorly understood. Both genetic and environmental factors&#xD;
      play a role and recent evidence suggests that gut microbiota is one of the key environmental&#xD;
      factors. Gut microbiota is increasingly being seen an important environmental risk factor for&#xD;
      multiple sclerosis, and strategies to correct an imbalance in intestinal flora.The first&#xD;
      study, &quot;Multiple sclerosis patients have a distinct gut microbiota compared to healthy&#xD;
      controls,&quot; published in Scientific Reports, found that people with relapsing-remitting MS&#xD;
      have altered fecal microbiota and may have microbial dysbiosis. People with MS had reduced&#xD;
      levels of a protein called aryl hydrocarbon receptor circulating in their blood.Aryl&#xD;
      hydrocarbon receptor is involved in many biological processes, including inflammation. The&#xD;
      researchers found that gut microbiota play a role in turning tryptophan, and amino acid found&#xD;
      in food, into Aryl hydrocarbon receptor agonists, which act on cells of the nervous system&#xD;
      called astrocytes and limit inflammation of the central nervous system. Low levels of Aryl&#xD;
      hydrocarbon receptor in multiple sclerosis patients may explain how microbial dysbiosis could&#xD;
      be causing the condition.Increased constipation and fecal incontinence and increased gut&#xD;
      permeability in multiple sclerosis patients, and increased occurrence of inflammatory bowel&#xD;
      diseases in MS patients and their families suggest an important gut-central nevus system&#xD;
      connection.Interestingly, gut bacteria can also influence the blood brain barrier integrity.&#xD;
      These studiesimplicate that gut microbiota may potentially be operational in predisposition&#xD;
      to or modification of the disease course of multiple sclerosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 4, 2018</start_date>
  <completion_date type="Anticipated">January 4, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 4, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Understanding the role of gut microbiota in the modification of the disease course of MS .</measure>
    <time_frame>24 month</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Multiple Sclerosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted in Assiut University hospital and outpatient clinic individuals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The study will included 40 cases of MS according to Diagnostic criteria of multiple&#xD;
             sclerosis they classified into two types of Multiple sclerosis ,Relapsing-remitting MS&#xD;
             (group 1), and Primary progressive MS, Secondary progressive MS, and Progressive&#xD;
             relapsing MS (group 2).&#xD;
&#xD;
        Each patient was submitted to the following:&#xD;
&#xD;
        Expanded disability status scale score between 1 and 6 and functional system score.&#xD;
&#xD;
        Demographic and clinical data (Age, sex, age of onset, severity of disease, clinical&#xD;
        symptoms and signs, Types of treatment, duration of treatment, number of attacks).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The general exclusion criteria included prior surgeries, any patients or controls&#xD;
             currently taking antibiotics or probiotic supplements,or having a known history of&#xD;
             disease with an disease such, rheumatoid arthritis,type-1-diabetes, and IBD, were also&#xD;
             excluded from the study.Microbial DNA was extracted from fecal material of each&#xD;
             sample.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eman Khadr, Professor</last_name>
    <phone>01005850632</phone>
    <email>Emankhadr99@yahoo.com</email>
  </overall_contact>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 27, 2017</last_update_submitted>
  <last_update_submitted_qc>August 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Azza Gama</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262870
org study id: GMAMS
nct id: NCT03262870
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Gut microbiota and multiple sclerosis Multiple sclerosis is a pro-inflammatory demyelinating
      disease of the central nervous system.
Multiple sclerosis is a pro-inflammatory demyelinating disease of the central nervous system.
      The etiology of MS is complex and poorly understood. Both genetic and environmental factors
      play a role and recent evidence suggests that gut microbiota is one of the key environmental
      factors. Gut microbiota is increasingly being seen an important environmental risk factor for
      multiple sclerosis, and strategies to correct an imbalance in intestinal flora.The first
      study, "Multiple sclerosis patients have a distinct gut microbiota compared to healthy
      controls," published in Scientific Reports, found that people with relapsing-remitting MS
      have altered fecal microbiota and may have microbial dysbiosis. People with MS had reduced
      levels of a protein called aryl hydrocarbon receptor circulating in their blood.Aryl
      hydrocarbon receptor is involved in many biological processes, including inflammation. The
      researchers found that gut microbiota play a role in turning tryptophan, and amino acid found
      in food, into Aryl hydrocarbon receptor agonists, which act on cells of the nervous system
      called astrocytes and limit inflammation of the central nervous system. Low levels of Aryl
      hydrocarbon receptor in multiple sclerosis patients may explain how microbial dysbiosis could
      be causing the condition.Increased constipation and fecal incontinence and increased gut
      permeability in multiple sclerosis patients, and increased occurrence of inflammatory bowel
      diseases in MS patients and their families suggest an important gut-central nevus system
      connection.Interestingly, gut bacteria can also influence the blood brain barrier integrity.
      These studiesimplicate that gut microbiota may potentially be operational in predisposition
      to or modification of the disease course of multiple sclerosis.
observational model: Case-Control
time perspective: Prospective
measure: Understanding the role of gut microbiota in the modification of the disease course of MS .
time frame: 24 month
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: No
last name: Eman Khadr, Professor
phone: 01005850632
email: Emankhadr99@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Azza Gama
investigator title: Dr
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: Undecided