<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/NCT03239197</url>
  </required_header>
  <id_info>
    <org_study_id>500-16-0004</org_study_id>
    <nct_id>NCT03239197</nct_id>
  </id_info>
  <brief_title>Project SHARE (motherS Have All the Right microbEs)</brief_title>
  <official_title>An Exploratory Study to Evaluate the Transfer of the Maternal Microbial Consortia to Infants During and Following Birth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kimberly-Clark Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kimberly-Clark Corporation</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>
      This is an exploratory study designed to collect microbial samples from several body&#xD;
      locations from 6 pairs of mothers and their newborn infants at various time points.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Sponsor request&#xD;
  </why_stopped>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Family-Based</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal staphylococci is transferred to infant during and following birth.</measure>
    <time_frame>6 weeks</time_frame>
    <description>presence of maternal staphylococci strain in infant</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Microbiota</condition>
  <arm_group>
    <arm_group_label>mother infant pair</arm_group_label>
    <description>mother infant pair, singleton infant, vaginal birth</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      staphlococci isolates&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant mothers and their infants, planning a vaginal birth and breastfeeding as primary&#xD;
        source of nutrition&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mother- pregnant female, singleton infant&#xD;
&#xD;
          -  Infant- vaginal birth, breastfeeding as primary source of nutrition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mother- antibiotic, steroid or antimicrobial use&#xD;
&#xD;
          -  Infant- antibiotic, steroid or antimicrobial use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Joseph Welter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marshfield Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marshfield Clinic</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.</citation>
    <PMID>19892944</PMID>
  </reference>
  <reference>
    <citation>Dowd SE, Sun Y, Wolcott RD, Domingo A, Carroll JA. Bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP) for microbiome studies: bacterial diversity in the ileum of newly weaned Salmonella-infected pigs. Foodborne Pathog Dis. 2008 Aug;5(4):459-72. doi: 10.1089/fpd.2008.0107.</citation>
    <PMID>18713063</PMID>
  </reference>
  <reference>
    <citation>Capone KA, Dowd SE, Stamatas GN, Nikolovski J. Diversity of the human skin microbiome early in life. J Invest Dermatol. 2011 Oct;131(10):2026-32. doi: 10.1038/jid.2011.168. Epub 2011 Jun 23.</citation>
    <PMID>21697884</PMID>
  </reference>
  <reference>
    <citation>Mueller NT, Bakacs E, Combellick J, Grigoryan Z, Dominguez-Bello MG. The infant microbiome development: mom matters. Trends Mol Med. 2015 Feb;21(2):109-17. doi: 10.1016/j.molmed.2014.12.002. Epub 2014 Dec 11.</citation>
    <PMID>25578246</PMID>
  </reference>
  <reference>
    <citation>Johnson CL, Versalovic J. The human microbiome and its potential importance to pediatrics. Pediatrics. 2012 May;129(5):950-60. doi: 10.1542/peds.2011-2736. Epub 2012 Apr 2.</citation>
    <PMID>22473366</PMID>
  </reference>
  <reference>
    <citation>Madan JC, Farzan SF, Hibberd PL, Karagas MR. Normal neonatal microbiome variation in relation to environmental factors, infection and allergy. Curr Opin Pediatr. 2012 Dec;24(6):753-9. doi: 10.1097/MOP.0b013e32835a1ac8.</citation>
    <PMID>23111681</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>December 8, 2017</last_update_submitted>
  <last_update_submitted_qc>December 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03239197
org study id: 500-16-0004
nct id: NCT03239197
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an exploratory study designed to collect microbial samples from several body
      locations from 6 pairs of mothers and their newborn infants at various time points.
observational model: Family-Based
time perspective: Prospective
measure: Maternal staphylococci is transferred to infant during and following birth.
time frame: 6 weeks
description: presence of maternal staphylococci strain in infant
arm group label: mother infant pair
description: mother infant pair, singleton infant, vaginal birth
staphlococci isolates
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Joseph Welter, MD
role: Principal Investigator
affiliation: Marshfield Clinic
facility: 
country: United States
citation: Costello EK, Lauber CL, Hamady M, Fierer N, Gordon JI, Knight R. Bacterial community variation in human body habitats across space and time. Science. 2009 Dec 18;326(5960):1694-7. doi: 10.1126/science.1177486. Epub 2009 Nov 5.
PMID: 19892944
citation: Dowd SE, Sun Y, Wolcott RD, Domingo A, Carroll JA. Bacterial tag-encoded FLX amplicon pyrosequencing (bTEFAP) for microbiome studies: bacterial diversity in the ileum of newly weaned Salmonella-infected pigs. Foodborne Pathog Dis. 2008 Aug;5(4):459-72. doi: 10.1089/fpd.2008.0107.
PMID: 18713063
citation: Capone KA, Dowd SE, Stamatas GN, Nikolovski J. Diversity of the human skin microbiome early in life. J Invest Dermatol. 2011 Oct;131(10):2026-32. doi: 10.1038/jid.2011.168. Epub 2011 Jun 23.
PMID: 21697884
citation: Mueller NT, Bakacs E, Combellick J, Grigoryan Z, Dominguez-Bello MG. The infant microbiome development: mom matters. Trends Mol Med. 2015 Feb;21(2):109-17. doi: 10.1016/j.molmed.2014.12.002. Epub 2014 Dec 11.
PMID: 25578246
citation: Johnson CL, Versalovic J. The human microbiome and its potential importance to pediatrics. Pediatrics. 2012 May;129(5):950-60. doi: 10.1542/peds.2011-2736. Epub 2012 Apr 2.
PMID: 22473366
citation: Madan JC, Farzan SF, Hibberd PL, Karagas MR. Normal neonatal microbiome variation in relation to environmental factors, infection and allergy. Curr Opin Pediatr. 2012 Dec;24(6):753-9. doi: 10.1097/MOP.0b013e32835a1ac8.
PMID: 23111681
responsible party type: Sponsor