<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/NCT02979210</url>
  </required_header>
  <id_info>
    <org_study_id>500-16-0003</org_study_id>
    <nct_id>NCT02979210</nct_id>
  </id_info>
  <brief_title>Infant Fecal Insult Study</brief_title>
  <official_title>Fecal Insult Study: An Exploratory Study to Evaluate the Microbial Consortia and Skin Barrier Function After Exposure to Artificial Fecal Irritants</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>
      The rationale for the study is to better understand the dynamics of skin microflora following&#xD;
      skin barrier disruption in an adult dermatitis model. The results from this study will&#xD;
      provide insights in the complex interaction between skin microbiome and epidermis under&#xD;
      normal and disease conditions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">February 1, 2017</completion_date>
  <primary_completion_date type="Actual">January 26, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Type of microbes present on skin after exposure to artificial fecal insult</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Microbes will be identified by metagenomic sequencing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relative abundance of microbes present on skin measured in picograms of DNA</measure>
    <time_frame>up to 7 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Dermatitis</condition>
  <arm_group>
    <arm_group_label>Artificial Fecal Insult</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Artificial Fecal Insult</intervention_name>
    <description>protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline</description>
    <arm_group_label>Artificial Fecal Insult</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Phosphate Buffered Saline</intervention_name>
    <description>200 microliters of phosphate buffered saline</description>
    <arm_group_label>Artificial Fecal Insult</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy Subjects with Fitzpatrick Skin Types I, II or III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with visible skin disease, tattoos, skin condition, or abnormal skin color&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Reliance Clinical Testing Service</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</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>Ishikawa J, Shimotoyodome Y, Ito S, Miyauchi Y, Fujimura T, Kitahara T, Hase T. Variations in the ceramide profile in different seasons and regions of the body contribute to stratum corneum functions. Arch Dermatol Res. 2013 Mar;305(2):151-62. doi: 10.1007/s00403-012-1286-5. Epub 2012 Sep 18.</citation>
    <PMID>22987221</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis</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/NCT02979210
org study id: 500-16-0003
nct id: NCT02979210
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The rationale for the study is to better understand the dynamics of skin microflora following
      skin barrier disruption in an adult dermatitis model. The results from this study will
      provide insights in the complex interaction between skin microbiome and epidermis under
      normal and disease conditions
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Type of microbes present on skin after exposure to artificial fecal insult
time frame: up to 7 days
description: Microbes will be identified by metagenomic sequencing
measure: Relative abundance of microbes present on skin measured in picograms of DNA
time frame: up to 7 days
arm group label: Artificial Fecal Insult
arm group type: Other
description: protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline)
intervention type: Other
intervention name: Artificial Fecal Insult
description: protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline
arm group label: Artificial Fecal Insult
intervention type: Other
intervention name: Phosphate Buffered Saline
description: 200 microliters of phosphate buffered saline
arm group label: Artificial Fecal Insult
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
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: Ishikawa J, Shimotoyodome Y, Ito S, Miyauchi Y, Fujimura T, Kitahara T, Hase T. Variations in the ceramide profile in different seasons and regions of the body contribute to stratum corneum functions. Arch Dermatol Res. 2013 Mar;305(2):151-62. doi: 10.1007/s00403-012-1286-5. Epub 2012 Sep 18.
PMID: 22987221
responsible party type: Sponsor
mesh term: Dermatitis
sharing ipd: Undecided