<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/NCT03236194</url>
  </required_header>
  <id_info>
    <org_study_id>PRAMS034493EP</org_study_id>
    <nct_id>NCT03236194</nct_id>
  </id_info>
  <brief_title>Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life</brief_title>
  <official_title>Ancillary Microbiome Collection From Mother/Infant Pairs During First Year of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Milton S. Hershey Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Milton S. Hershey Medical Center</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>
      The investigators will be studying the development of the microbiome over the first year&#xD;
      after birth in light of various environmental influences - e.g. mode of delivery, diet (and&#xD;
      diet changes), antibiotic exposure, GERD medication exposure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay&#xD;
      through the first year of life. Investigators will perform statistical analyses to test the&#xD;
      hypotheses (1) that there is an association between the developing oral and gut microbiomes,&#xD;
      and (2) that they interact in affecting childhood obesity.&#xD;
&#xD;
      This study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring&#xD;
      oral and gut microbiome collected from that study's second born participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</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>Microbiome outcome</measure>
    <time_frame>birth to 1 year</time_frame>
    <description>Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Genetic variation</measure>
    <time_frame>birth to 1 year</time_frame>
    <description>Associations between genetic variation and microbiome diversity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Genetic variation</measure>
    <time_frame>birth to 1 year</time_frame>
    <description>Genetic variation as it relates to growth outcomes</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Infant Development</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      microbiome samples from mother and infant&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy full-term mothers and infants delivering at the Penn State Milton S Hershey Medical&#xD;
        center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. full-term infant (&gt; 36 0/7 weeks gestational age) without significant morbidity&#xD;
&#xD;
          2. nursery/NICU/maternity stay of 7 days or less&#xD;
&#xD;
          3. participant children can be (but do not have to be) twins&#xD;
&#xD;
          4. English speaking mother&#xD;
&#xD;
          5. care provided at an HMC affiliated clinic&#xD;
&#xD;
          6. a working telephone number&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. prenatal ultrasound presence of intrauterine growth retardation (IUGR)&#xD;
&#xD;
          2. infant birth weight &lt;2250 grams&#xD;
&#xD;
          3. presence of a congenital anomaly or neonatal condition that significantly affects a&#xD;
             newborn's feeding (e.g. cleft lip, cleft palate, metabolic disease)&#xD;
&#xD;
          4. any major maternal morbidities and/or pre-existing condition that would affect&#xD;
             postpartum care or her ability to care for her newborn such as cancer, multiple&#xD;
             sclerosis, lupus, etc.&#xD;
&#xD;
          5. plan for newborn to be adopted&#xD;
&#xD;
          6. plan to move from Central Pennsylvania within 1 year&#xD;
&#xD;
          7. have 2 older siblings in INSIGHT/SIBSIGHT (NIH funded study related to this ancillary&#xD;
             study)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Gomez A, Nelson KE. The Oral Microbiome of Children: Development, Disease, and Implications Beyond Oral Health. Microb Ecol. 2017 Feb;73(2):492-503. doi: 10.1007/s00248-016-0854-1. Epub 2016 Sep 14.</citation>
    <PMID>27628595</PMID>
  </reference>
  <reference>
    <citation>Gritz EC, Bhandari V. The human neonatal gut microbiome: a brief review. Front Pediatr. 2015 Mar 5;3:17. doi: 10.3389/fped.2015.00017. eCollection 2015. Erratum In: Front Pediatr. 2015;3:60.</citation>
    <PMID>25798435</PMID>
  </reference>
  <reference>
    <citation>Chu DM, Ma J, Prince AL, Antony KM, Seferovic MD, Aagaard KM. Maturation of the infant microbiome community structure and function across multiple body sites and in relation to mode of delivery. Nat Med. 2017 Mar;23(3):314-326. doi: 10.1038/nm.4272. Epub 2017 Jan 23.</citation>
    <PMID>28112736</PMID>
  </reference>
  <reference>
    <citation>Backhed F, Roswall J, Peng Y, Feng Q, Jia H, Kovatcheva-Datchary P, Li Y, Xia Y, Xie H, Zhong H, Khan MT, Zhang J, Li J, Xiao L, Al-Aama J, Zhang D, Lee YS, Kotowska D, Colding C, Tremaroli V, Yin Y, Bergman S, Xu X, Madsen L, Kristiansen K, Dahlgren J, Wang J. Dynamics and Stabilization of the Human Gut Microbiome during the First Year of Life. Cell Host Microbe. 2015 Jun 10;17(6):852. doi: 10.1016/j.chom.2015.05.012. Epub 2015 Jun 10. No abstract available.</citation>
    <PMID>26308884</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>February 28, 2019</last_update_submitted>
  <last_update_submitted_qc>February 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Milton S. Hershey Medical Center</investigator_affiliation>
    <investigator_full_name>Ian M. Paul, MD</investigator_full_name>
    <investigator_title>Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics</investigator_title>
  </responsible_party>
  <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/NCT03236194
org study id: PRAMS034493EP
nct id: NCT03236194
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will be studying the development of the microbiome over the first year
      after birth in light of various environmental influences - e.g. mode of delivery, diet (and
      diet changes), antibiotic exposure, GERD medication exposure.
Microbiome samples will be collected from mother/infant pairs during post-natal hospital stay
      through the first year of life. Investigators will perform statistical analyses to test the
      hypotheses (1) that there is an association between the developing oral and gut microbiomes,
      and (2) that they interact in affecting childhood obesity.

      This study relates to the INSIGHT study (NCT01167270) and its last outcome measure; exploring
      oral and gut microbiome collected from that study's second born participants.
observational model: Cohort
time perspective: Prospective
measure: Microbiome outcome
time frame: birth to 1 year
description: Microbiome diversity within individuals (how gut and oral microbiomes are similar or different) and between individuals
measure: Genetic variation
time frame: birth to 1 year
description: Associations between genetic variation and microbiome diversity
measure: Genetic variation
time frame: birth to 1 year
description: Genetic variation as it relates to growth outcomes
microbiome samples from mother and infant
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Gomez A, Nelson KE. The Oral Microbiome of Children: Development, Disease, and Implications Beyond Oral Health. Microb Ecol. 2017 Feb;73(2):492-503. doi: 10.1007/s00248-016-0854-1. Epub 2016 Sep 14.
PMID: 27628595
citation: Gritz EC, Bhandari V. The human neonatal gut microbiome: a brief review. Front Pediatr. 2015 Mar 5;3:17. doi: 10.3389/fped.2015.00017. eCollection 2015. Erratum In: Front Pediatr. 2015;3:60.
PMID: 25798435
citation: Chu DM, Ma J, Prince AL, Antony KM, Seferovic MD, Aagaard KM. Maturation of the infant microbiome community structure and function across multiple body sites and in relation to mode of delivery. Nat Med. 2017 Mar;23(3):314-326. doi: 10.1038/nm.4272. Epub 2017 Jan 23.
PMID: 28112736
citation: Backhed F, Roswall J, Peng Y, Feng Q, Jia H, Kovatcheva-Datchary P, Li Y, Xia Y, Xie H, Zhong H, Khan MT, Zhang J, Li J, Xiao L, Al-Aama J, Zhang D, Lee YS, Kotowska D, Colding C, Tremaroli V, Yin Y, Bergman S, Xu X, Madsen L, Kristiansen K, Dahlgren J, Wang J. Dynamics and Stabilization of the Human Gut Microbiome during the First Year of Life. Cell Host Microbe. 2015 Jun 10;17(6):852. doi: 10.1016/j.chom.2015.05.012. Epub 2015 Jun 10. No abstract available.
PMID: 26308884
responsible party type: Principal Investigator
investigator affiliation: Milton S. Hershey Medical Center
investigator full name: Ian M. Paul, MD
investigator title: Professor of Pediatrics and Public Health Sciences Chief, Division of Academic General Pediatrics Vice Chair of Clinical Affairs, Department of Pediatrics
sharing ipd: Undecided