<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/NCT02970513</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-0288</org_study_id>
    <secondary_id>2016-A01233-48</secondary_id>
    <nct_id>NCT02970513</nct_id>
  </id_info>
  <brief_title>Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery</brief_title>
  <acronym>MicrobioPSY</acronym>
  <official_title>Psychological Evaluation According Colonic Colonization by Escherichia Coli of Patients After Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      The purpose of this study is to determine whether the presence of pathogenic Escherichia coli&#xD;
      in colon is associated with psychiatric disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colonic colonization by pathogenic Escherichia coli was determined when patients were&#xD;
      operated on for colorectal cancer.&#xD;
&#xD;
      Several years later, the investigator investigate past and actual psychiatric disorder using&#xD;
      the Mini International Neuropsychiatric Interview (MINI). Actual depression and anxiety&#xD;
      scores are evaluated with Hamilton scales and personality traits are investigated using&#xD;
      Personality Inventory for DSM-5 (PID-5).&#xD;
&#xD;
      Anxiety and depression scores, psychiatric diagnoses (MINI) and personality traits were&#xD;
      compared in patients according to Escherichia coli presence/absence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2017</start_date>
  <completion_date type="Actual">October 27, 2017</completion_date>
  <primary_completion_date type="Actual">September 27, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hamilton anxiety and depression score comparison</measure>
    <time_frame>at day 1</time_frame>
    <description>Hamilton anxiety and depression score will be compared between patients with Escherichi coli colonic colonization and patients without Escherichi coli</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Psychiatric prevalence comparison</measure>
    <time_frame>at day 1</time_frame>
    <description>prevalence of each past and actual psychiatric disorder diagnosed by the Mini International Neuropsychiatric Interview (MINI: major depression, dysthymia, suicidal risk, hypomania, mania, panic disorder, agoraphobia, social phobia, specific phobia, obsessive-compulsive disorder, posttraumatic stress disorder, dependence and abuse of alcohol, tobacco- dependence, psychotic disorders and generalized anxiety disorder) will be compared in patients according to colonic colonization by Escherichia coli.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>personality traits comparison</measure>
    <time_frame>at day 1</time_frame>
    <description>personality traits investigated using Personality Inventory for DSM-5 (PID-5) will be compared in patients according colonic colonization by Escherichia coli</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>patients operated on for colorectal cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychiatric evaluation</intervention_name>
    <description>The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.</description>
    <arm_group_label>patients operated on for colorectal cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients operated on for colorectal cancer in the digestive surgery department of&#xD;
             Clermont-Ferrand hospital&#xD;
&#xD;
          -  patients older than 18 years,&#xD;
&#xD;
          -  patients whose Escherichia coli colonization was analyzed after surgery&#xD;
&#xD;
          -  patients which are always followed by the digestive surgery department.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with dementia will not be included, according to the MMSE score:&#xD;
&#xD;
          -  22 if no grade&#xD;
&#xD;
          -  23 if study certificate or CAP or college without patent&#xD;
&#xD;
          -  25 if patent or school without the tray&#xD;
&#xD;
          -  26 or more when bin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Isabelle JALENQUES</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Escherichia coli</keyword>
  <keyword>Microbiota</keyword>
  <keyword>Colorectal cancer</keyword>
  <keyword>Psychiatric disorders</keyword>
  <keyword>Personality traits</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Escherichia coli Infections</mesh_term>
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02970513
org study id: CHU-0288
secondary id: 2016-A01233-48
nct id: NCT02970513
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether the presence of pathogenic Escherichia coli
      in colon is associated with psychiatric disorders.
Colonic colonization by pathogenic Escherichia coli was determined when patients were
      operated on for colorectal cancer.

      Several years later, the investigator investigate past and actual psychiatric disorder using
      the Mini International Neuropsychiatric Interview (MINI). Actual depression and anxiety
      scores are evaluated with Hamilton scales and personality traits are investigated using
      Personality Inventory for DSM-5 (PID-5).

      Anxiety and depression scores, psychiatric diagnoses (MINI) and personality traits were
      compared in patients according to Escherichia coli presence/absence.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Hamilton anxiety and depression score comparison
time frame: at day 1
description: Hamilton anxiety and depression score will be compared between patients with Escherichi coli colonic colonization and patients without Escherichi coli
measure: Psychiatric prevalence comparison
time frame: at day 1
description: prevalence of each past and actual psychiatric disorder diagnosed by the Mini International Neuropsychiatric Interview (MINI: major depression, dysthymia, suicidal risk, hypomania, mania, panic disorder, agoraphobia, social phobia, specific phobia, obsessive-compulsive disorder, posttraumatic stress disorder, dependence and abuse of alcohol, tobacco- dependence, psychotic disorders and generalized anxiety disorder) will be compared in patients according to colonic colonization by Escherichia coli.
measure: personality traits comparison
time frame: at day 1
description: personality traits investigated using Personality Inventory for DSM-5 (PID-5) will be compared in patients according colonic colonization by Escherichia coli
arm group label: patients operated on for colorectal cancer
arm group type: Experimental
intervention type: Other
intervention name: Psychiatric evaluation
description: The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.
arm group label: patients operated on for colorectal cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Isabelle JALENQUES
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Escherichia coli Infections
mesh term: Colorectal Neoplasms