<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/NCT03001167</url>
  </required_header>
  <id_info>
    <org_study_id>15-012623</org_study_id>
    <secondary_id>R01AI121383</secondary_id>
    <nct_id>NCT03001167</nct_id>
  </id_info>
  <brief_title>Microbiome, Antibiotics, and Growth Infant Cohort</brief_title>
  <acronym>MAGIC</acronym>
  <official_title>Early Life Antibiotics, Gut Microbiome Development, and Risk of Childhood Obesity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth&#xD;
      cohort to determine the relationships between early life antibiotic exposure, microbiome&#xD;
      development, growth, antibodies, and immunostimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Perinatal and infant antibiotic exposures are common and have been linked to changes in the&#xD;
      gut microbiome, which plays a central role in health and disease. Childhood obesity is an&#xD;
      epidemic and animal models have linked antibiotic induced changes in the microbiome with&#xD;
      increased adiposity. Infants become colonized with trillions of bacteria in the first few&#xD;
      hours of life. During this time period, their nascent immune system develops tolerance to&#xD;
      commensal microbes&#xD;
&#xD;
      The primary objectives are to measure the impact of common perinatal and early childhood&#xD;
      antibiotic exposures on the structure and function of the developing gut microbiome. To&#xD;
      determine the association between common perinatal and early childhood antibiotic exposures&#xD;
      and weight/adiposity gain in a large birth cohort of children. To determine mechanisms for&#xD;
      the association between microbiome changes over time and the rate of weight/adiposity gain in&#xD;
      a large birth cohort of children. To determine the normal developmental pattern by which&#xD;
      healthy children develop antibodies in their blood against the microbes that naturally&#xD;
      colonize their intestines. To determine the association between immunostimulation and&#xD;
      protection from persistent colonization in humans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cumulative microbial diversity</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>weight trajectory adjusted for time varying length</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>total number of individual bacterial taxa</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>expression levels of bacterial gene categories</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fat stores in the upper arm/extremity</measure>
    <time_frame>24 months</time_frame>
    <description>Skinfolds at the triceps are measured (0.1 mm) with a skinfold caliper</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fat stores in the upper back/trunk</measure>
    <time_frame>24 months</time_frame>
    <description>Skinfolds at the superiliac and subscapular sites are measured (0.1 mm) with a skinfold caliper</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>supine length trajectory</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>determine the association between immunostimulation and protection from persistent colonization in humans</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use autologous serum antibodies to &quot;tag&quot; fecal microbes</measure>
    <time_frame>24 months</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">500</enrollment>
  <condition>Obesity, Childhood</condition>
  <condition>Antibiotic Side Effect</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool samples Saliva samples nasal swab skin swabs blood draw cord blood heel stick&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Our study population will be comprised of children born at Pennsylvania Hospital between&#xD;
        2016-2018 and subsequently, followed in the Children's Hospital of Philadelphia (CHOP) Care&#xD;
        Network or one of four other local primary care pediatric practices.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born at Pennsylvania Hospital&#xD;
&#xD;
          -  Recruited at &lt; 120 hours of age&#xD;
&#xD;
          -  Born at 36 0/7 weeks gestation&#xD;
&#xD;
          -  Birth weight ≥ 2000 grams&#xD;
&#xD;
          -  Parents plan to receive well-child care in the Children's Hospital of Philadelphia&#xD;
             (CHOP) network, Society Hill Pediatrics, Center City Pediatrics, Penn Medicine or&#xD;
             South Philly Pediatrics&#xD;
&#xD;
          -  Biological mother is the legal guardian, or the child is born from a surrogacy with&#xD;
             guardianship immediately transferred in hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child in neonatal intensive care unit (NICU) for ≥ 120 cumulative hours&#xD;
&#xD;
          -  Biological mother NOT legal guardian&#xD;
&#xD;
          -  Biological mother NOT primary caretaker&#xD;
&#xD;
          -  Biological mother &lt; 18 years of age&#xD;
&#xD;
          -  Child has culture confirmed-infection&#xD;
&#xD;
          -  Biological mother is non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>96 Hours</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeffrey S Gerber, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dan Knights, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://magicstudy.research.chop.edu/</url>
    <description>Official study website</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Microbiome</keyword>
  <keyword>Antibiotics</keyword>
  <keyword>Growth</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>De-identified individual participant data will be shared with collaborators at the Knights Lab at the University of Minnesota.</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/NCT03001167
org study id: 15-012623
secondary id: R01AI121383
nct id: NCT03001167
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This cross-disciplinary study will assemble and longitudinally follow a large, diverse birth
      cohort to determine the relationships between early life antibiotic exposure, microbiome
      development, growth, antibodies, and immunostimulation.
Perinatal and infant antibiotic exposures are common and have been linked to changes in the
      gut microbiome, which plays a central role in health and disease. Childhood obesity is an
      epidemic and animal models have linked antibiotic induced changes in the microbiome with
      increased adiposity. Infants become colonized with trillions of bacteria in the first few
      hours of life. During this time period, their nascent immune system develops tolerance to
      commensal microbes

      The primary objectives are to measure the impact of common perinatal and early childhood
      antibiotic exposures on the structure and function of the developing gut microbiome. To
      determine the association between common perinatal and early childhood antibiotic exposures
      and weight/adiposity gain in a large birth cohort of children. To determine mechanisms for
      the association between microbiome changes over time and the rate of weight/adiposity gain in
      a large birth cohort of children. To determine the normal developmental pattern by which
      healthy children develop antibodies in their blood against the microbes that naturally
      colonize their intestines. To determine the association between immunostimulation and
      protection from persistent colonization in humans.
observational model: Cohort
time perspective: Prospective
measure: cumulative microbial diversity
time frame: 24 months
measure: weight trajectory adjusted for time varying length
time frame: 24 months
measure: total number of individual bacterial taxa
time frame: 24 months
measure: expression levels of bacterial gene categories
time frame: 24 months
measure: fat stores in the upper arm/extremity
time frame: 24 months
description: Skinfolds at the triceps are measured (0.1 mm) with a skinfold caliper
measure: fat stores in the upper back/trunk
time frame: 24 months
description: Skinfolds at the superiliac and subscapular sites are measured (0.1 mm) with a skinfold caliper
measure: supine length trajectory
time frame: 24 months
measure: determine the association between immunostimulation and protection from persistent colonization in humans
time frame: 24 months
measure: Use autologous serum antibodies to "tag" fecal microbes
time frame: 24 months
Stool samples Saliva samples nasal swab skin swabs blood draw cord blood heel stick
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 96 Hours
healthy volunteers: No
last name: Jeffrey S Gerber, MD, PhD
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
last name: Dan Knights, PhD
role: Principal Investigator
affiliation: University of Minnesota
facility: 
country: United States
url: https://magicstudy.research.chop.edu/
description: Official study website
responsible party type: Sponsor
mesh term: Obesity
mesh term: Pediatric Obesity
sharing ipd: No
ipd description: De-identified individual participant data will be shared with collaborators at the Knights Lab at the University of Minnesota.