<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/NCT03791866</url>
  </required_header>
  <id_info>
    <org_study_id>YKK17102</org_study_id>
    <nct_id>NCT03791866</nct_id>
  </id_info>
  <brief_title>The Th9/IL-9 and Early Enteral Nutrition in Sepsis</brief_title>
  <official_title>The Roles of Th9/IL-9 in the Mechanisms of Early Enteral Nutrition Maintaining Intestinal Mucosal Barrier in Sepsis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing First Hospital, Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanjing First Hospital, Nanjing Medical 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>
      The investigators aim to evaluate the roles of Th9/IL-9 in the mechanisms of early enteral&#xD;
      nutrition (EEN) maintaining intestinal mucosal barrier in sepsis. The results of this study&#xD;
      would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of&#xD;
      sepsis and provide a new idea to the early treatment of sepsis. In addition, the&#xD;
      investigators also aim to evaluate the effects of different proportions of target total&#xD;
      enteral nutrition on the prognosis of sepsis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>28-d mortality</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Th9 lymphocyte percentages</measure>
    <time_frame>7 days</time_frame>
    <description>Serum Th9 lymphocyte percentages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of serum IL-9</measure>
    <time_frame>7 days</time_frame>
    <description>Concentration of serum IL-9</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of serum iFABP</measure>
    <time_frame>7 days</time_frame>
    <description>Concentration of serum iFABP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of serum DAO</measure>
    <time_frame>7 days</time_frame>
    <description>Concentration of serum DAO</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Sepsis</condition>
  <condition>Intestinal Mucosal Barrier</condition>
  <condition>Th9 Cells</condition>
  <condition>Enteral Nutrition</condition>
  <arm_group>
    <arm_group_label>30% target total enteral nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>60% target total enteral nutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>100% target total enteral nutrition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nutrition</intervention_name>
    <description>Enteral nutrition</description>
    <arm_group_label>100% target total enteral nutrition</arm_group_label>
    <arm_group_label>30% target total enteral nutrition</arm_group_label>
    <arm_group_label>60% target total enteral nutrition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of sepsis&#xD;
&#xD;
          2. Within 3 days of sepsis onset before ICU admission&#xD;
&#xD;
          3. No artificial nutrition (enteral or parenteral nutrition) were provided before ICU&#xD;
             admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ileus&#xD;
&#xD;
          2. Digestive tract hemorrhage&#xD;
&#xD;
          3. Inflammatory bowel disease&#xD;
&#xD;
          4. Abdominal hypertension (IAP &gt;25mmHg)&#xD;
&#xD;
          5. Cancer or chronic organ dysfunction (e.g., hepatic or renal dysfunction)&#xD;
&#xD;
          6. Malnutrition or immunodeficiency&#xD;
&#xD;
          7. Long-term use of hormones&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jia-Kui Sun</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jie Zhou</last_name>
    <phone>+8613913893984</phone>
    <email>565219791@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Zhou</last_name>
      <phone>+8613913893984</phone>
      <email>565219791@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>December 31, 2018</last_update_submitted>
  <last_update_submitted_qc>December 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Nanjing First Hospital, Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>XiangWang</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</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/NCT03791866
org study id: YKK17102
nct id: NCT03791866
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators aim to evaluate the roles of Th9/IL-9 in the mechanisms of early enteral
      nutrition (EEN) maintaining intestinal mucosal barrier in sepsis. The results of this study
      would lay the foundation for revealing the mechanisms of EEN improving immune imbalance of
      sepsis and provide a new idea to the early treatment of sepsis. In addition, the
      investigators also aim to evaluate the effects of different proportions of target total
      enteral nutrition on the prognosis of sepsis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: 28-d mortality
time frame: 28 days
measure: Serum Th9 lymphocyte percentages
time frame: 7 days
description: Serum Th9 lymphocyte percentages
measure: Concentration of serum IL-9
time frame: 7 days
description: Concentration of serum IL-9
measure: Concentration of serum iFABP
time frame: 7 days
description: Concentration of serum iFABP
measure: Concentration of serum DAO
time frame: 7 days
description: Concentration of serum DAO
arm group label: 30% target total enteral nutrition
arm group type: Experimental
arm group label: 60% target total enteral nutrition
arm group type: Experimental
arm group label: 100% target total enteral nutrition
arm group type: Active Comparator
intervention type: Other
intervention name: Nutrition
description: Enteral nutrition
arm group label: 100% target total enteral nutrition
arm group label: 30% target total enteral nutrition
arm group label: 60% target total enteral nutrition
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jia-Kui Sun
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: Jie Zhou
phone: +8613913893984
email: 565219791@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Nanjing First Hospital, Nanjing Medical University
investigator full name: XiangWang
investigator title: Director
mesh term: Sepsis
mesh term: Toxemia