<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/NCT04451148</url>
  </required_header>
  <id_info>
    <org_study_id>103/20</org_study_id>
    <nct_id>NCT04451148</nct_id>
  </id_info>
  <brief_title>Gut Microbiome and Obesity</brief_title>
  <acronym>MATOMS</acronym>
  <official_title>Gut Microbiome As Target of Intervention Against Obesity and Metabolic Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II 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>
      Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor&#xD;
      for various chronic non-communicable diseases. Metabolic syndrome (MS) is the name for a&#xD;
      group of risk factors that increase cardiovascular risk and other health problems&#xD;
      characterized by the presence of abdominal obesity, dyslipidemia, hyperglycaemia and high&#xD;
      blood pressure. Numerous preclinical and clinical data suggest a potential role of the&#xD;
      intestinal microbiota in these diseaes. Unfortunately, comparative studies of the gut&#xD;
      microbiota are still scarce in pediatric subjects suffering from obesity than obesity&#xD;
      complicated by MS. The aim is to study the metagenomics and metabolomics characteristics of&#xD;
      the intestinal microbiota in obese children/adolescents with or without MS, that could&#xD;
      provide useful data for innovative intervention strategies for these conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2022</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>Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls</measure>
    <time_frame>at enrollment</time_frame>
    <description>Evaluation of gut microbiota composition</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls</measure>
    <time_frame>at enrollment</time_frame>
    <description>Evaluation of butyrate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls</measure>
    <time_frame>at enrollment</time_frame>
    <description>Evaluation of acetate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls</measure>
    <time_frame>at enrollment</time_frame>
    <description>Evaluation of propionate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls</measure>
    <time_frame>at enrollment</time_frame>
    <description>Evaluation of indole</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Obesity, Childhood</condition>
  <condition>Metabolic Syndrome</condition>
  <arm_group>
    <arm_group_label>Obese subjects</arm_group_label>
    <description>Subjects with obesity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese plus metabolic syndrome subjects</arm_group_label>
    <description>Subjects with obesity and metabolic syndrome</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy controls</arm_group_label>
    <description>Otherwise healthy subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Obese with or without metabolic syndromesubjects</intervention_name>
    <description>Children with obesity and with or without metabolic syndrome</description>
    <arm_group_label>Obese plus metabolic syndrome subjects</arm_group_label>
    <arm_group_label>Obese subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children/adolescents of both sexes, aged between 10-16 years, with obesity, obesity&#xD;
        complicated by metabolic syndrome and healthy controls observed at Pediatrics Section of&#xD;
        Department of Translational Medical Sciences (University of Naples Federico II)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged between 10-16 years,&#xD;
&#xD;
          -  diagnosis of obesity or obesity complicated by metabolic syndrome&#xD;
&#xD;
          -  healthy controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age at enrollment &lt; 10 or &gt;16 years,&#xD;
&#xD;
          -  concomitant presence of chronic diseases,&#xD;
&#xD;
          -  neoplasms,&#xD;
&#xD;
          -  immunodeficiencies,&#xD;
&#xD;
          -  chronic infections,&#xD;
&#xD;
          -  autoimmune diseases,&#xD;
&#xD;
          -  chronic inflammatory bowel diseases,&#xD;
&#xD;
          -  celiac disease, -genetic-metabolic diseases, -&#xD;
&#xD;
          -  cystic fibrosis&#xD;
&#xD;
          -  chronic lung diseases,&#xD;
&#xD;
          -  malformations of the cardiovascular/respiratory/gastrointestinal system,&#xD;
&#xD;
          -  neuropsychiatric disorders&#xD;
&#xD;
          -  neurological pathologies,&#xD;
&#xD;
          -  assumption of antibiotics and/or pre/pro/synbiotics&#xD;
&#xD;
          -  onset of diarrhea or acute gastrointestinal disease during the 12 weeks prior to&#xD;
             enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>University of Naples Federico II</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roberto Berni Canani, MD, PhD</last_name>
      <phone>+390817462680</phone>
      <email>berni@unina.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Roberto Berni Canani</investigator_full_name>
    <investigator_title>MD, Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
    <mesh_term>Syndrome</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/NCT04451148
org study id: 103/20
nct id: NCT04451148
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pediatric obesity is a risk factor for the onset of obesity in adulthood and is a risk factor
      for various chronic non-communicable diseases. Metabolic syndrome (MS) is the name for a
      group of risk factors that increase cardiovascular risk and other health problems
      characterized by the presence of abdominal obesity, dyslipidemia, hyperglycaemia and high
      blood pressure. Numerous preclinical and clinical data suggest a potential role of the
      intestinal microbiota in these diseaes. Unfortunately, comparative studies of the gut
      microbiota are still scarce in pediatric subjects suffering from obesity than obesity
      complicated by MS. The aim is to study the metagenomics and metabolomics characteristics of
      the intestinal microbiota in obese children/adolescents with or without MS, that could
      provide useful data for innovative intervention strategies for these conditions.
observational model: Case-Control
time perspective: Prospective
measure: Concentration of metagenomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
time frame: at enrollment
description: Evaluation of gut microbiota composition
measure: Concentration of metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
time frame: at enrollment
description: Evaluation of butyrate
measure: Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
time frame: at enrollment
description: Evaluation of acetate
measure: Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
time frame: at enrollment
description: Evaluation of propionate
measure: Concentration of the metabolomic characteristics of the intestinal microbiota in subjects with obesity, obesity complicated by metabolic syndrome and healthy controls
time frame: at enrollment
description: Evaluation of indole
arm group label: Obese subjects
description: Subjects with obesity
arm group label: Obese plus metabolic syndrome subjects
description: Subjects with obesity and metabolic syndrome
arm group label: Healthy controls
description: Otherwise healthy subjects
intervention type: Other
intervention name: Obese with or without metabolic syndromesubjects
description: Children with obesity and with or without metabolic syndrome
arm group label: Obese plus metabolic syndrome subjects
arm group label: Obese subjects
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 10 Years
maximum age: 16 Years
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Roberto Berni Canani
investigator title: MD, Associate Professor
mesh term: Obesity
mesh term: Metabolic Syndrome
mesh term: Pediatric Obesity
mesh term: Syndrome
sharing ipd: Undecided