<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/NCT03264690</url>
  </required_header>
  <id_info>
    <org_study_id>D2E7-M082-602</org_study_id>
    <nct_id>NCT03264690</nct_id>
  </id_info>
  <brief_title>Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients</brief_title>
  <acronym>ETERNITY</acronym>
  <official_title>A Prospective Study to Observe the Change in Microbiome in Human Derived Sample and the Relation With Clinical Response Before and After the Anti-TNF Treatment in IBD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Korea Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to observe the difference in microbiome composition between&#xD;
      healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor&#xD;
      necrosis factor (anti-TNF) treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 21, 2017</start_date>
  <completion_date type="Actual">January 16, 2020</completion_date>
  <primary_completion_date type="Actual">January 16, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3</measure>
    <time_frame>Month 3</time_frame>
    <description>Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants</measure>
    <time_frame>Baseline</time_frame>
    <description>Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC)</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Disease activity will be assessed by CDAI to quantify the symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation in the composition of the microbiome at baseline and disease activity will be assessed as measured by CDAI or Mayo score at Month 3</measure>
    <time_frame>Baseline; Month 3</time_frame>
    <description>The composition of the microbiome at baseline will be correlated to disease activity which is assessed as measured by CDAI or Mayo score at Month 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in calprotectin at Month 3</measure>
    <time_frame>Baseline; Month 3</time_frame>
    <description>Fecal calprotectin can indicate inflammation in the intestines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with abnormal, clinically significant vital signs</measure>
    <time_frame>Up to 3 months</time_frame>
    <description>Clinical significance will be determined by the investigator.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>Microbial composition measured from IBD and non-IBD groups</arm_group_label>
    <description>Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female participants diagnosed with inflammatory bowel disease (IBD) will be&#xD;
        compared to participants with non-IBD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Inclusion/ Exclusion Criteria:&#xD;
&#xD;
               1. Inclusion Criteria For Inflammatory Bowel Disease (IBD) participants:&#xD;
&#xD;
                    -  Male or female, age ≥ 19 years at the time of informed consent&#xD;
&#xD;
                    -  Confirmed diagnosis of IBD&#xD;
&#xD;
                    -  Participants who are naïve to anti-tumour necrosis factor (anti-TNF)&#xD;
&#xD;
               2. Exclusion Criteria for IBD participants:&#xD;
&#xD;
                    -  Contraindication to anti-TNF including active tuberculosis (TB), sepsis, or&#xD;
                       other severe opportunistic infection, etc.&#xD;
&#xD;
          2. Inclusion/ Exclusion Criteria:&#xD;
&#xD;
               1. Inclusion Criteria for non-IBD participants:&#xD;
&#xD;
                    -  Participants who have not been diagnosed with IBD&#xD;
&#xD;
                    -  Participants who don't have any other intestinal disease except IBD&#xD;
&#xD;
                    -  Participants who are naïve to anti-TNF&#xD;
&#xD;
               2. Exclusion Criteria for non-IBD participants:&#xD;
&#xD;
                    -  Participants who have been on medication to treat underlying disease for the&#xD;
                       previous 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eisai Trial Site # 1</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 2</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 3</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Crohn's disease</keyword>
  <keyword>Ulcerative colitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammatory Bowel Diseases</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/NCT03264690
org study id: D2E7-M082-602
nct id: NCT03264690
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will be conducted to observe the difference in microbiome composition between
      healthy participants and inflammatory bowel disease (IBD) participants with no anti-tumor
      necrosis factor (anti-TNF) treatment.
observational model: Cohort
time perspective: Prospective
measure: Change in the composition of the microbiome after anti-tumour necrosis factor (anti-TNF) treatment for inflammatory bowel disease (IBD) at Month 3
time frame: Month 3
description: Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed.
measure: The difference in the composition of the microbiome at baseline between IBD participants and non-IBD participants
time frame: Baseline
description: Microbiome is the microorganisms in a particular environment (including the body or a part of the body). Changes in the microbiome in fecal, blood, saliva, and urine samples before and after anti-TNF treatment will be assessed.
measure: Disease activity will be assessed by Crohn's Disease Activity Index (CDAI) or Mayo score for ulcerative colitis (UC)
time frame: Up to 3 months
description: Disease activity will be assessed by CDAI to quantify the symptoms.
measure: Correlation in the composition of the microbiome at baseline and disease activity will be assessed as measured by CDAI or Mayo score at Month 3
time frame: Baseline; Month 3
description: The composition of the microbiome at baseline will be correlated to disease activity which is assessed as measured by CDAI or Mayo score at Month 3.
measure: Change from baseline in calprotectin at Month 3
time frame: Baseline; Month 3
description: Fecal calprotectin can indicate inflammation in the intestines.
measure: Number of participants with abnormal, clinically significant vital signs
time frame: Up to 3 months
description: Clinical significance will be determined by the investigator.
arm group label: Microbial composition measured from IBD and non-IBD groups
description: Participants with inflammatory bowel disease (IBD) and non-IBD will be measured for microbial composition.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Inflammatory Bowel Diseases