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/NCT06035029</url>
    </required_header>
    <id_info>
      <org_study_id>YXLL-KY-2023 （009）</org_study_id>
      <nct_id>NCT06035029</nct_id>
    </id_info>
    <brief_title>Intestinal Flora and Metabonomics of Appendicitis</brief_title>
    <official_title>Research on Intestinal Flora and Metabonomics of Appendicitis in Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>HongyiQu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qianfoshan Hospital</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 goal of this observational study is to learn about the key bacterial flora and&#xD;
        metabolites associated with appendicitis in children. The main questions it aims to answer&#xD;
        are:&#xD;
  &#xD;
          -  To screen out the key biomarkers of pediatric appendicitis.&#xD;
  &#xD;
          -  What are the microbial differences in different parts of pediatric appendicitis&#xD;
             patients.&#xD;
  &#xD;
        Participants will detect feces using 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing&#xD;
        technology and differences of the fecal metabolites between healthy children and appendicitis&#xD;
        children were analyzed using untargeted metabolomics based on Liquid chromatography-tandem&#xD;
        mass spectrometry(LC-M S/MS) platform.Through the analysis of intestinal bacterial flora and&#xD;
        metabolomics association and the differential analysis of intestinal bacterial flora in&#xD;
        different parts of the case group, the key bacterial flora and metabolites were excavated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Participants will detect feces using 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing&#xD;
        technology and differences of the fecal metabolites between healthy children and appendicitis&#xD;
        children were analyzed using untargeted metabolomics based on Liquid chromatography-tandem&#xD;
        mass spectrometry(LC-M S/MS) platform.&#xD;
  &#xD;
        Differences in the intestinal flora of different parts of the case group: the intestinal&#xD;
        flora of the case group in feces and rectum were detected by 16s ribosomal RiboNucleicAcid&#xD;
        (16S rRNA) gene sequencing technology, and the intestinal flora of different parts were&#xD;
        analyzed and compared.&#xD;
  &#xD;
        Through the analysis of intestinal bacterial flora and metabolomics association and the&#xD;
        differential analysis of intestinal bacterial flora in different parts of the case group, the&#xD;
        key bacterial flora and metabolites were excavated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 3, 2023</start_date>
    <completion_date type="Anticipated">July 2025</completion_date>
    <primary_completion_date type="Anticipated">January 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>The 16S rRNA gene sequence</measure>
      <time_frame>up to 24 weeks</time_frame>
      <description>Samples were qualified for Polymerase Chain Reaction(PCR) amplification of the V3 and V4 variable regions of the 16 rRNA gene. The Polymerase Chain Reaction(PCR) products were then quantified by confirming the presence of PCR amplicons by gel electrophoresis on a 2% agarose gel and staining with ethidium bromide, and equimolar amounts (100 ng) of PCR amplicons were pooled prior to pyrosequencing. High-throughput sequencing of the qualified 16S amplicon libraries.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fecal untargeted metabolomics testing</measure>
      <time_frame>up to 24 weeks</time_frame>
      <description>To analyze the fecal metabolite differences and the correlation of appendicitis and metabolites using untargeted metabolomics based on the LC-M S/MS platform. To screen key metabolites in pediatric appendicitis.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Appendicitis</condition>
    <condition>Intestinal Metaplasia</condition>
    <condition>Metabonomics</condition>
    <arm_group>
      <arm_group_label>Case group</arm_group_label>
      <description>Children with appendectomy for appendicitis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Children with no digestive disease or medical history</description>
    </arm_group>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Before antibiotics for children in the case group, a stool sample (5-10 g) was collected from&#xD;
        all of the included subjects and placed in a sterile enzyme-free (no RNA and DNA enzyme)&#xD;
        cryopreservation tube.&#xD;
  &#xD;
        When children with appendicitis are taken to the operating room and placed under anesthesia,&#xD;
        the patient is collected and collected after storage using sterile preservation fluid. After&#xD;
        the appendectomy, the full length of the appendix cavity was wiped with a sterile cotton swab&#xD;
        under a sterile environment, and then the swab was placed into a sterile collection tube.&#xD;
        Specimens were transported and stored at-80℃ until analysis.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Children aged 1-14 in Department of Pediatric Surgery in Shandong Qianfoshan Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children aged 1-14 years who were initially diagnosed with appendicitis and underwent&#xD;
               laparoscopic appendectomy&#xD;
  &#xD;
            -  Children aged 1-14 years with non-digestive tract disease and no history of digestive&#xD;
               tract disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  A family history of intestinal disease&#xD;
  &#xD;
            -  Allergic to antibiotic therapy drugs&#xD;
  &#xD;
            -  Patients with long-term drug use causing microbial structure changes or intestinal&#xD;
               flora disorders&#xD;
  &#xD;
            -  Patients with other congenital diseases such as Meckel's diverticulum, intestinal&#xD;
               rotation and other malrotation&#xD;
  &#xD;
            -  With other systemic diseases, such as obvious upper respiratory tract infection or&#xD;
               myocarditis&#xD;
  &#xD;
            -  Children with other digestive system diseases after auxiliary examination or surgical&#xD;
               diagnosis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>14 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qu</last_name>
      <role>Study Chair</role>
      <affiliation>The First Affiliated Hospital of Shandong First Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qu</last_name>
      <phone>+8613905316435</phone>
      <email>qhyzhl8083@126.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The First Affiliated Hospital Of Shandong First Medcial Unversity</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>0531</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qu</last_name>
        <phone>+8613905316435</phone>
        <email>qhyzhl8083@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Qianfoshan Hospital</investigator_affiliation>
      <investigator_full_name>HongyiQu</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Appendicitis</mesh_term>
      <mesh_term>Metaplasia</mesh_term>
    </condition_browse>
    <!-- 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/NCT06035029
  org study id: YXLL-KY-2023 （009）
  nct id: NCT06035029
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about the key bacterial flora and
        metabolites associated with appendicitis in children. The main questions it aims to answer
        are:
  
          -  To screen out the key biomarkers of pediatric appendicitis.
  
          -  What are the microbial differences in different parts of pediatric appendicitis
             patients.
  
        Participants will detect feces using 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing
        technology and differences of the fecal metabolites between healthy children and appendicitis
        children were analyzed using untargeted metabolomics based on Liquid chromatography-tandem
        mass spectrometry(LC-M S/MS) platform.Through the analysis of intestinal bacterial flora and
        metabolomics association and the differential analysis of intestinal bacterial flora in
        different parts of the case group, the key bacterial flora and metabolites were excavated.
  Participants will detect feces using 16s ribosomal RiboNucleicAcid (16S rRNA) gene sequencing
        technology and differences of the fecal metabolites between healthy children and appendicitis
        children were analyzed using untargeted metabolomics based on Liquid chromatography-tandem
        mass spectrometry(LC-M S/MS) platform.
  
        Differences in the intestinal flora of different parts of the case group: the intestinal
        flora of the case group in feces and rectum were detected by 16s ribosomal RiboNucleicAcid
        (16S rRNA) gene sequencing technology, and the intestinal flora of different parts were
        analyzed and compared.
  
        Through the analysis of intestinal bacterial flora and metabolomics association and the
        differential analysis of intestinal bacterial flora in different parts of the case group, the
        key bacterial flora and metabolites were excavated.
  observational model: Case-Control
  time perspective: Prospective
  measure: The 16S rRNA gene sequence
  time frame: up to 24 weeks
  description: Samples were qualified for Polymerase Chain Reaction(PCR) amplification of the V3 and V4 variable regions of the 16 rRNA gene. The Polymerase Chain Reaction(PCR) products were then quantified by confirming the presence of PCR amplicons by gel electrophoresis on a 2% agarose gel and staining with ethidium bromide, and equimolar amounts (100 ng) of PCR amplicons were pooled prior to pyrosequencing. High-throughput sequencing of the qualified 16S amplicon libraries.
  measure: Fecal untargeted metabolomics testing
  time frame: up to 24 weeks
  description: To analyze the fecal metabolite differences and the correlation of appendicitis and metabolites using untargeted metabolomics based on the LC-M S/MS platform. To screen key metabolites in pediatric appendicitis.
  arm group label: Case group
  description: Children with appendectomy for appendicitis
  arm group label: Control group
  description: Children with no digestive disease or medical history
  Before antibiotics for children in the case group, a stool sample (5-10 g) was collected from
        all of the included subjects and placed in a sterile enzyme-free (no RNA and DNA enzyme)
        cryopreservation tube.
  
        When children with appendicitis are taken to the operating room and placed under anesthesia,
        the patient is collected and collected after storage using sterile preservation fluid. After
        the appendectomy, the full length of the appendix cavity was wiped with a sterile cotton swab
        under a sterile environment, and then the swab was placed into a sterile collection tube.
        Specimens were transported and stored at-80℃ until analysis.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 14 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Qu
  role: Study Chair
  affiliation: The First Affiliated Hospital of Shandong First Medical University
  last name: Qu
  phone: +8613905316435
  email: qhyzhl8083@126.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Qianfoshan Hospital
  investigator full name: HongyiQu
  investigator title: professor
  mesh term: Appendicitis
  mesh term: Metaplasia