xml: <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/NCT06026020</url>
    </required_header>
    <id_info>
      <org_study_id>K4434</org_study_id>
      <nct_id>NCT06026020</nct_id>
    </id_info>
    <brief_title>Pathogenesis of Intestinal Behcet's Syndrome</brief_title>
    <official_title>Exploration of the Pathogenesis of Intestinal Behcet's Syndrome: a Single-center Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
        There is a direct interaction between food, intestinal flora and the intestinal barrier&#xD;
        composed of intestinal epithelial cells and mucosal immunity, whose composition and&#xD;
        functional alterations are theorized to be closely related to the development of&#xD;
        gastrointestinal (GI) involvement in Behcet's syndrome (BS) patients. Therefore, this study&#xD;
        focuses on the population of patients with intestinal BS and explores the unique mechanisms&#xD;
        leading to intestinal involvement in BS patients in terms of the characteristics of&#xD;
        intestinal microecology. Since oral ulcers are one of the most common clinical manifestations&#xD;
        in BS patients, in addition to intestinal flora analysis, this application project also plans&#xD;
        to collect saliva samples from patients in the hope of obtaining a holistic understanding of&#xD;
        mucosal flora in different parts of the entire GI tract. Serological testing and analysis&#xD;
        will also be performed, focusing on changes in the intestinal tract and serum IgE levels, and&#xD;
        analyzed in conjunction with microbiomics to provide evidence to further elucidate the&#xD;
        pathogenesis of BS and GI involvement, and to search for more efficient therapeutic&#xD;
        strategies, in terms of a variety of aspects, including clinical manifestations and disease&#xD;
        progression.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">September 2025</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>Structure and composition of gut microbiota</measure>
      <time_frame>Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)</time_frame>
      <description>DNA extraction from stool samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the gut microbiota among different groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Structure and composition of oral microbiota</measure>
      <time_frame>Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)</time_frame>
      <description>DNA extraction from saliva samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the oral microbiota among different groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Structure and composition of metabolomics</measure>
      <time_frame>Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)</time_frame>
      <description>Serum extraction from blood samples will be tested through non-targeted metabolomics techniques to analysis and compare metabolomics among different groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum level of Immunoglobulin E</measure>
      <time_frame>Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)</time_frame>
      <description>Serum extraction from blood samples will be used to test and compare the level of IgE among different groups.</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Behcet's Syndrome, Intestinal Type</condition>
    <arm_group>
      <arm_group_label>Behcet's syndrome patients with intestinal involvement</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Behcet's syndrome patients without intestinal involvement</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Inflammatory bowel disease patients</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Health control</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Biological samples collection</intervention_name>
      <description>Samples of blood, faeces, saliva are collected for analysis.</description>
      <arm_group_label>Behcet's syndrome patients with intestinal involvement</arm_group_label>
      <arm_group_label>Behcet's syndrome patients without intestinal involvement</arm_group_label>
      <arm_group_label>Health control</arm_group_label>
      <arm_group_label>Inflammatory bowel disease patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient who have Behcet's syndrome with or without intestinal involvement, compared with&#xD;
          inflammatory bowel disease patients and health controls.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Behcet's syndrome patients with intestinal involvement:&#xD;
  &#xD;
            -  Attendance at Peking Union Medical College Hospital, fulfillment of one of the two&#xD;
               diagnostic criteria for BS (1990 Criteria of International Study Group for Behcet's&#xD;
               disease or 2014 International Criteria for Behçet's Disease), and well-documented&#xD;
               medical records;&#xD;
  &#xD;
            -  Age 20-65 years old;&#xD;
  &#xD;
            -  Have evidence of GI involvement, including clinical manifestations, laboratory tests,&#xD;
               endoscopy, imaging and pathology;&#xD;
  &#xD;
            -  Signed written informed consent and willingness to cooperate.&#xD;
  &#xD;
          Behcet's syndrome patients with intestinal involvement:&#xD;
  &#xD;
            -  Attendance at Peking Union Medical College Hospital, fulfillment of one of the two&#xD;
               diagnostic criteria for BS (1990 Criteria of International Study Group for Behcet's&#xD;
               disease or 2014 International Criteria for Behçet's Disease), and well-documented&#xD;
               medical records;&#xD;
  &#xD;
            -  Age 20-65 years old;&#xD;
  &#xD;
            -  Have no evidence of GI involvement, including clinical manifestations, laboratory&#xD;
               tests, endoscopy, imaging and pathology;&#xD;
  &#xD;
            -  Signed written informed consent and willingness to cooperate.&#xD;
  &#xD;
          Inflammatory bowel disease patients:&#xD;
  &#xD;
            -  Attended Peking Union Medical College Hospital and was diagnosed with Crohn's disease&#xD;
               by a combination of clinical, imaging, and pathologic diagnosis;&#xD;
  &#xD;
            -  Age 20-65 years old;&#xD;
  &#xD;
            -  Signed written informed consent and willingness to cooperate.&#xD;
  &#xD;
          Health controls:&#xD;
  &#xD;
            -  Healthy individuals aged 20-65 years;&#xD;
  &#xD;
            -  Signed written informed consent and willingness to cooperate.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other systemic diseases, such as autoimmune diseases, infectious diseases, malignant&#xD;
               tumors, etc;&#xD;
  &#xD;
            -  Patients with other intestinal diseases, such as intestinal tumors, intestinal&#xD;
               tuberculosis, intestinal infections;&#xD;
  &#xD;
            -  Patients with other oral diseases, such as cavity caries, oral abscesses, oral tumors,&#xD;
               oral candidiasis, and dry mouth;&#xD;
  &#xD;
            -  Patients taking antibiotics and probiotics within one month.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Dong Wu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dong Wu</last_name>
      <phone>18612671010</phone>
      <email>wudong@pumch.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dong Wu</last_name>
        <phone>18612671010</phone>
        <email>wudong@pumch.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Behcet's syndrome</keyword>
    <keyword>intestinal Behcet's syndrome</keyword>
    <keyword>inflammatory bowel disease</keyword>
    <keyword>microbiome</keyword>
    <keyword>metabolomics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Behcet Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026020
  org study id: K4434
  nct id: NCT06026020
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  There is a direct interaction between food, intestinal flora and the intestinal barrier
        composed of intestinal epithelial cells and mucosal immunity, whose composition and
        functional alterations are theorized to be closely related to the development of
        gastrointestinal (GI) involvement in Behcet's syndrome (BS) patients. Therefore, this study
        focuses on the population of patients with intestinal BS and explores the unique mechanisms
        leading to intestinal involvement in BS patients in terms of the characteristics of
        intestinal microecology. Since oral ulcers are one of the most common clinical manifestations
        in BS patients, in addition to intestinal flora analysis, this application project also plans
        to collect saliva samples from patients in the hope of obtaining a holistic understanding of
        mucosal flora in different parts of the entire GI tract. Serological testing and analysis
        will also be performed, focusing on changes in the intestinal tract and serum IgE levels, and
        analyzed in conjunction with microbiomics to provide evidence to further elucidate the
        pathogenesis of BS and GI involvement, and to search for more efficient therapeutic
        strategies, in terms of a variety of aspects, including clinical manifestations and disease
        progression.
  observational model: Case-Control
  time perspective: Prospective
  measure: Structure and composition of gut microbiota
  time frame: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
  description: DNA extraction from stool samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the gut microbiota among different groups.
  measure: Structure and composition of oral microbiota
  time frame: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
  description: DNA extraction from saliva samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the oral microbiota among different groups.
  measure: Structure and composition of metabolomics
  time frame: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
  description: Serum extraction from blood samples will be tested through non-targeted metabolomics techniques to analysis and compare metabolomics among different groups.
  measure: Serum level of Immunoglobulin E
  time frame: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
  description: Serum extraction from blood samples will be used to test and compare the level of IgE among different groups.
  arm group label: Behcet's syndrome patients with intestinal involvement
  arm group label: Behcet's syndrome patients without intestinal involvement
  arm group label: Inflammatory bowel disease patients
  arm group label: Health control
  intervention type: Other
  intervention name: Biological samples collection
  description: Samples of blood, faeces, saliva are collected for analysis.
  arm group label: Behcet's syndrome patients with intestinal involvement
  arm group label: Behcet's syndrome patients without intestinal involvement
  arm group label: Health control
  arm group label: Inflammatory bowel disease patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dong Wu
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: Dong Wu
  phone: 18612671010
  email: wudong@pumch.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Behcet Syndrome
  mesh term: Syndrome
  sharing ipd: No