<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/NCT03755583</url>
  </required_header>
  <id_info>
    <org_study_id>IBD-EEN-microbiota</org_study_id>
    <nct_id>NCT03755583</nct_id>
  </id_info>
  <brief_title>Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Gastrointestinal Microbiota for Chinese Children With Crohn's Disease</brief_title>
  <official_title>Effect of Exclusive Enteral Nutrition on Disease Process, Nutritional Status and Intestinal Microbiota for Chinese Children With Crohn's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital of Fudan University</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the&#xD;
      inflammation results from sustained abnormal immune response towards altered or pathogenic&#xD;
      microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in&#xD;
      pediatric Crohn's disease(CD). Exclusive enteral nutrion(EEN) has been shown to improve&#xD;
      nutritional status and inflammatory markers in pediatric CD. But there is limited data about&#xD;
      the effect of EEN on Chinese children with CD. In this study, investigators focused on&#xD;
      disease process,nutritional status and gut microbiome of Chinese children with&#xD;
      newly-diagnosed CD after EEN treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>5-item gut microbiota measure</measure>
    <time_frame>0, 2, 6, 8, 12 weeks post-EEN</time_frame>
    <description>the change of gut microbiota during EEN and after the end of EEN</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2-item Simple Endoscopic Score for CD (SES-CD)</measure>
    <time_frame>0, 8, weeks post-EEN</time_frame>
    <description>According to the SES-CD, at the end of EEN, the patients whose SES-CD scores were ≤4 were classified into the remission group (CD-RE), other patients whose SES-CD scores were &gt;4 were classified into the non-remission group (CD-NRE)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)</measure>
    <time_frame>0, 2, 6, 8, 12 weeks post-EEN</time_frame>
    <description>wPCDAI scoret included 8 items (Abdominal pain, Patient functioning, Stools, ESR, Albumin, Weight, Perirectal disease, Extraintestinal manifestations ).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)</measure>
    <time_frame>0,8 weeks post-EEN</time_frame>
    <description>the level of 25-OH VITD3 in 8 weeks post-EEN is higher than 0 week represents a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-item weight measure</measure>
    <time_frame>0, 2, 6, 8, 12 weeks post-EEN</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-item height measure</measure>
    <time_frame>0, 2, 6, 8, 12 weeks post-EEN</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>5-item Fecal Calprotectin</measure>
    <time_frame>0, 2, 6, 8, 12 weeks post-EEN</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-item Insulin-like growth factor-1</measure>
    <time_frame>0, 8 weeks post-EEN</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2-item Calcium, vitamin</measure>
    <time_frame>0, 8 weeks post-EEN</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Crohn Disease</condition>
  <condition>Enteral Nutrition</condition>
  <condition>Gastrointestinal Microbiome</condition>
  <arm_group>
    <arm_group_label>EEN group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Received exclusive enteral nutrition after enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Exclusive Enteral Nutrition</intervention_name>
    <description>a complete liquid diet of formula for 8 weeks were adminstered in Crohn's Diseas patients ,Nutritional intake was based on the child's estimated energy requirements, no regular table food during 8 weeks treament.</description>
    <arm_group_label>EEN group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric CD patients who were newly diagnosed and being treated with EEN at the&#xD;
             Children's Hospital of Fudan University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) patients who were administered corticosteroids, immunosuppressive drugs, or&#xD;
             biological agents prior to the study; (2) patients who could not finish the daily&#xD;
             prescribed volume of formula for any reason; (3) patients who could not attend&#xD;
             consecutive follow-up sessions; (4) patients who had received antibiotics or&#xD;
             probiotics within 1.5 months prior to the study; and (5) patients who had been given&#xD;
             corticosteroids, immunosuppressive drugs, biological agents, antibiotics, or&#xD;
             probiotics during the EEN process.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's hospital of Fudan university</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>201102</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>January 23, 2020</last_update_submitted>
  <last_update_submitted_qc>January 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital of Fudan University</investigator_affiliation>
    <investigator_full_name>Ying HUANG</investigator_full_name>
    <investigator_title>The director of gastroenterology of Children's Hospital of Fudan University</investigator_title>
  </responsible_party>
  <keyword>Exclusive enteral nutrition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT03755583
org study id: IBD-EEN-microbiota
nct id: NCT03755583
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Inflammatory bowel diseases (IBD) are chronic inflammatory diseases. It is believed that the
      inflammation results from sustained abnormal immune response towards altered or pathogenic
      microbiota in genetically susceptible hosts. Malnutrition is common in IBD, especially in
      pediatric Crohn's disease(CD). Exclusive enteral nutrion(EEN) has been shown to improve
      nutritional status and inflammatory markers in pediatric CD. But there is limited data about
      the effect of EEN on Chinese children with CD. In this study, investigators focused on
      disease process,nutritional status and gut microbiome of Chinese children with
      newly-diagnosed CD after EEN treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 5-item gut microbiota measure
time frame: 0, 2, 6, 8, 12 weeks post-EEN
description: the change of gut microbiota during EEN and after the end of EEN
measure: 2-item Simple Endoscopic Score for CD (SES-CD)
time frame: 0, 8, weeks post-EEN
description: According to the SES-CD, at the end of EEN, the patients whose SES-CD scores were ≤4 were classified into the remission group (CD-RE), other patients whose SES-CD scores were >4 were classified into the non-remission group (CD-NRE)
measure: 5-item weighted Paediatric Crohn's disease activity index measure(wPCDAI)
time frame: 0, 2, 6, 8, 12 weeks post-EEN
description: wPCDAI scoret included 8 items (Abdominal pain, Patient functioning, Stools, ESR, Albumin, Weight, Perirectal disease, Extraintestinal manifestations ).
measure: 2-item 25-hydroxyvitamin D3 measure (25-OH VITD3)
time frame: 0,8 weeks post-EEN
description: the level of 25-OH VITD3 in 8 weeks post-EEN is higher than 0 week represents a better outcome
measure: 5-item weight measure
time frame: 0, 2, 6, 8, 12 weeks post-EEN
measure: 5-item height measure
time frame: 0, 2, 6, 8, 12 weeks post-EEN
measure: 5-item Fecal Calprotectin
time frame: 0, 2, 6, 8, 12 weeks post-EEN
measure: 2-item Insulin-like growth factor-1
time frame: 0, 8 weeks post-EEN
measure: 2-item Calcium, vitamin
time frame: 0, 8 weeks post-EEN
arm group label: EEN group
arm group type: Other
description: Received exclusive enteral nutrition after enrollment.
intervention type: Dietary Supplement
intervention name: Exclusive Enteral Nutrition
description: a complete liquid diet of formula for 8 weeks were adminstered in Crohn's Diseas patients ,Nutritional intake was based on the child's estimated energy requirements, no regular table food during 8 weeks treament.
arm group label: EEN group
criteria: 
gender: All
minimum age: 1 Year
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital of Fudan University
investigator full name: Ying HUANG
investigator title: The director of gastroenterology of Children's Hospital of Fudan University
mesh term: Crohn Disease
sharing ipd: Undecided