<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/NCT03812497</url>
  </required_header>
  <id_info>
    <org_study_id>Microbiome and metabolome</org_study_id>
    <nct_id>NCT03812497</nct_id>
  </id_info>
  <brief_title>Pediatric Obesity Related Metabolite Profile and Gut Microbiota</brief_title>
  <official_title>Interplay Between Pediatric Obesity Related Plasma Metabolite Profile and Gut Microbiota</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hallym University Kangnam Sacred Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hallym University Kangnam Sacred Heart 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>
      In this study, the investigators aimed to observe changes in the gut microbial composition&#xD;
      before and after the weight-loss intervention, including dietary control and exercise, in&#xD;
      obese children. The main metabolites produced by gut microbiome, short chain fatty acids&#xD;
      (SCFAs) will be also analysed. The investigators will analyse the change of gut microbiome&#xD;
      composition and metabolites related with weight-loss intervention and the relationship&#xD;
      between microbiome composition and metabolites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Many recent studies have suggested that dysbiosis of the gut microbiome might related to&#xD;
      obesity. There is growing evidence that the composition of gut microbiome changes in&#xD;
      childhood obesity compared to normal-weight children, and it is attracting attention as an&#xD;
      adjustable environmental factor in obesity treatment. It has been reported that gut&#xD;
      microbiome could be changed due to environmental influences such as diet and exercise. In&#xD;
      this study, the investigators aimed to observe changes in the gut microbial composition&#xD;
      before and after the weight-loss intervention, including dietary control and exercise, in&#xD;
      obese children. The main metabolites produced by gut microbiome, short chain fatty acids&#xD;
      (SCFAs) would be also analysed to investigate the relationship with gut microbiome and with&#xD;
      weight-loss intervention. Intervention is not performed for normal-weight children, and&#xD;
      samples from normal-weight children will be used as a control for gut microbiome and&#xD;
      biochemical tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">June 28, 2018</start_date>
  <completion_date type="Anticipated">June 28, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>Intervention arm: every obese children will have individualized education program about diet control and exercise in usual life.&#xD;
Control arm: normal weight children</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in gut microbiome composition in stool samples</measure>
    <time_frame>up to 3 months after enrollment</time_frame>
    <description>Bacterial diversity and composition using 16s rRNA sequencing. Especially Bacteroidetes and Firmicutes populations in fecal microbiome will be analyzed related with obesity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in short chain fatty acids of fecal samples</measure>
    <time_frame>up to 12 months after enrollment</time_frame>
    <description>The main metabolites produced by gut microbiome, short chain fatty acids using gas chromatography- mass-spectrometry.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The relationship between gut microbiome composition and fecal short chain fatty acid</measure>
    <time_frame>up to 12 months after enrollment</time_frame>
    <description>The relationship between gut microbiome composition and metabolites will be analyzed by canonical correspondence analysis</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Obesity, Childhood</condition>
  <arm_group>
    <arm_group_label>Obese Children Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To reduce the weight, every obese children will receive individualized education program about a way of dietary control and exercise in their usual life. This individualized education program, developed by investigators, specialized dietitian and exercise teacher, is scheduled once a month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Weight Children Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Normal weight children</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individualized Education Program</intervention_name>
    <description>The every participants will have individualized education program about a way of dietary control and exercise in their usual life.</description>
    <arm_group_label>Obese Children Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obese children: Children ≥95 ‰&#xD;
&#xD;
          -  Non-obese children: 5‰&lt;BMI &lt;85 ‰&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking antibiotics, probiotics, or steroids for a month before visit&#xD;
&#xD;
          -  Taking probiotics-like products including yogurt for seven days before visit&#xD;
&#xD;
          -  Having enteritis symptoms including diarrhea for a month before visit&#xD;
&#xD;
          -  Chronic heart disease, chronic bowel disease, chronic liver disease, chronic kidney&#xD;
             disease, endocrine disease, genetic diseases or congenital metabolic disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ky Young Cho, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kangnam Sacred Heart Hospital, Hallym University College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hallym University Kangnam Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>07440</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>May 15, 2020</last_update_submitted>
  <last_update_submitted_qc>May 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hallym University Kangnam Sacred Heart Hospital</investigator_affiliation>
    <investigator_full_name>Ky Young Cho</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Microbiome</keyword>
  <keyword>Metabolome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Study participants will only agree if IPD is not shared.</ipd_description>
  </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/NCT03812497
org study id: Microbiome and metabolome
nct id: NCT03812497
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigators aimed to observe changes in the gut microbial composition
      before and after the weight-loss intervention, including dietary control and exercise, in
      obese children. The main metabolites produced by gut microbiome, short chain fatty acids
      (SCFAs) will be also analysed. The investigators will analyse the change of gut microbiome
      composition and metabolites related with weight-loss intervention and the relationship
      between microbiome composition and metabolites.
Many recent studies have suggested that dysbiosis of the gut microbiome might related to
      obesity. There is growing evidence that the composition of gut microbiome changes in
      childhood obesity compared to normal-weight children, and it is attracting attention as an
      adjustable environmental factor in obesity treatment. It has been reported that gut
      microbiome could be changed due to environmental influences such as diet and exercise. In
      this study, the investigators aimed to observe changes in the gut microbial composition
      before and after the weight-loss intervention, including dietary control and exercise, in
      obese children. The main metabolites produced by gut microbiome, short chain fatty acids
      (SCFAs) would be also analysed to investigate the relationship with gut microbiome and with
      weight-loss intervention. Intervention is not performed for normal-weight children, and
      samples from normal-weight children will be used as a control for gut microbiome and
      biochemical tests.
allocation: Non-Randomized
intervention model: Factorial Assignment
intervention model description: Intervention arm: every obese children will have individualized education program about diet control and exercise in usual life.
Control arm: normal weight children
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in gut microbiome composition in stool samples
time frame: up to 3 months after enrollment
description: Bacterial diversity and composition using 16s rRNA sequencing. Especially Bacteroidetes and Firmicutes populations in fecal microbiome will be analyzed related with obesity.
measure: Changes in short chain fatty acids of fecal samples
time frame: up to 12 months after enrollment
description: The main metabolites produced by gut microbiome, short chain fatty acids using gas chromatography- mass-spectrometry.
measure: The relationship between gut microbiome composition and fecal short chain fatty acid
time frame: up to 12 months after enrollment
description: The relationship between gut microbiome composition and metabolites will be analyzed by canonical correspondence analysis
arm group label: Obese Children Group
arm group type: Experimental
description: To reduce the weight, every obese children will receive individualized education program about a way of dietary control and exercise in their usual life. This individualized education program, developed by investigators, specialized dietitian and exercise teacher, is scheduled once a month.
arm group label: Normal Weight Children Group
arm group type: No Intervention
description: Normal weight children
intervention type: Behavioral
intervention name: Individualized Education Program
description: The every participants will have individualized education program about a way of dietary control and exercise in their usual life.
arm group label: Obese Children Group
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ky Young Cho, Ph.D.
role: Principal Investigator
affiliation: Kangnam Sacred Heart Hospital, Hallym University College of Medicine
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Hallym University Kangnam Sacred Heart Hospital
investigator full name: Ky Young Cho
investigator title: Associate professor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No
ipd description: Study participants will only agree if IPD is not shared.