xml: <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/NCT06001450</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY-23-00245</org_study_id>
      <secondary_id>22-1179-00001</secondary_id>
      <nct_id>NCT06001450</nct_id>
    </id_info>
    <brief_title>Pregnant Women With and Without Crohns Disease to Explore the Role of Plastics and Toxins in Intestinal Inflammation</brief_title>
    <acronym>PLANET</acronym>
    <official_title>PLANET: Exploring the Role of Plastics and Toxins in Intestinal Inflammation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Aalborg University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The PLANET Study aims to determine the impact of microplastics on intestinal inflammation and&#xD;
        gut microbiome in order to understand the role of this pollutant on the risk of developing&#xD;
        inflammatory bowel disease (IBD) as well as other diseases. With this information, the&#xD;
        researchers hope to characterize better the role of environmental pollutants on IBD and&#xD;
        develop novel strategies towards prevention.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC),&#xD;
        is a chronic, progressive inflammatory disease of the intestinal tract. The etiology of IBD&#xD;
        is not well understood, but believed to result from a complex relationship between genetics,&#xD;
        environment, and gut microbiome alterations, resulting in a self-perpetuating, abnormal&#xD;
        mucosal immune response. The incidence of IBD is rising in developing and recently developed&#xD;
        countries, highlighting the importance of environmental exposures in determining disease&#xD;
        risk. Microplastics, defined as plastic particles &lt;5 mm in size, are ubiquitous pollutants&#xD;
        with unclear implications towards human health. Emerging studies indicate substantial&#xD;
        disruption of intestinal immune function and a proinflammatory milieu due to microplastics.&#xD;
        Therefore, identifying, and characterizing microplastics in stool samples of individuals with&#xD;
        CD alongside alterations in microbiome and calprotectin, which are events that occur prior to&#xD;
        CD onset, is the initial step in exploring the impact of microplastics on IBD. Moreover, CD&#xD;
        affects women during their reproductive years and 25% become pregnant after diagnosis. Given&#xD;
        that maternal IBD diagnosis is one of the major risks of future IBD in offspring, it is&#xD;
        critical to better understand if babies born to mothers with IBD have higher content of&#xD;
        microplastics or other toxins in the stools and whether these levels correlate with those of&#xD;
        their mothers during pregnancy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 23, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 23, 2024</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>Microplastics quantification</measure>
      <time_frame>1 year</time_frame>
      <description>Measuring the concentration, size and shape distributions of microplastics in the stool samples of women with CD, healthy controls and any relatives (spouses and siblings of the infant).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Alpha and beta diversity</measure>
      <time_frame>1 year</time_frame>
      <description>Microbiome characterization - Bacterial DNA will be isolated from stool and sequenced to characterize the bacteria present in the microbiome. Alpha and beta diversity statistics will be reported.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Fecal calprotectin analysis</measure>
      <time_frame>1 year</time_frame>
      <description>Stool samples will be processed to quantify calprotectin levels which are routinely used to characterize inflammation.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Crohns Disease</condition>
    <condition>Pregnancy</condition>
    <condition>Inflammatory Bowel Disease</condition>
    <arm_group>
      <arm_group_label>Pregnant people with Crohns disease (Case)</arm_group_label>
      <description>Arm 1 is pregnant people with Crohns disease who enroll with the infant that they are pregnant with at the time.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Pregnant people without Crohns disease (Control)</arm_group_label>
      <description>Arm 2 is the control arm of pregnant people without Crohns disease and other inflammatory bowel diseases who enroll with the infant that they are pregnant with at the time.</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Stool, Saliva, Breast milk, Whole Blood (optional), Cord Blood (optional), Placenta&#xD;
        (optional)&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnant people 18 years and older, with and without Crohns disease.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The ability to sign and date an informed consent form&#xD;
  &#xD;
            -  Be pregnant, or wishing to become pregnant in the near future and enroll the infant&#xD;
               that the individual is pregnant with&#xD;
  &#xD;
            -  Aged 18 or older&#xD;
  &#xD;
            -  English-speaking (this observational study uses non-validated questionnaires that are&#xD;
               only available in English)&#xD;
  &#xD;
            -  Of any ethnicity&#xD;
  &#xD;
            -  Be a spouse, related household member (sibling, parent, etc.) or a child of an&#xD;
               enrolled pregnant person&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals who are unable to give informed consent&#xD;
  &#xD;
            -  Be diagnosed with a pregnancy complication, such as intrauterine fetal&#xD;
               demise/stillbirth, preeclampsia, hyperemesis gravidarum, or have an active infection,&#xD;
               including chorioamnionitis or sepsis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Manasi Agrawal, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mellissa Picker, BS</last_name>
      <phone>212-659-6710</phone>
      <phone_ext>86710</phone_ext>
      <email>mellissa.picker@mssm.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Icahn School of Medicine at Mount Sinai</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10128</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mellissa Picker, BS</last_name>
        <phone>212-659-6710</phone>
        <phone_ext>86710</phone_ext>
        <email>mellissa.picker@mssm.edu</email>
      </contact>
      <investigator>
        <last_name>Manasi Agrawal</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://labs.icahn.mssm.edu/peterlab/planet-study/</url>
      <description>You can find frequently asked questions, contact information and information about our lab at this link.</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Manasi Agrawal</investigator_full_name>
      <investigator_title>Assistant Professor of Medicine</investigator_title>
    </responsible_party>
    <keyword>microplastics</keyword>
    <keyword>nanoplastics</keyword>
    <keyword>pregnancy</keyword>
    <keyword>pollution</keyword>
    <keyword>environmental pollutants</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Crohn Disease</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no blanket statement on IPD as some participants may opt out of data sharing in collaborations and the researchers will not be submitting data to any repositories.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06001450
  org study id: STUDY-23-00245
  secondary id: 22-1179-00001
  nct id: NCT06001450
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The PLANET Study aims to determine the impact of microplastics on intestinal inflammation and
        gut microbiome in order to understand the role of this pollutant on the risk of developing
        inflammatory bowel disease (IBD) as well as other diseases. With this information, the
        researchers hope to characterize better the role of environmental pollutants on IBD and
        develop novel strategies towards prevention.
  Inflammatory bowel disease (IBD), including Crohn's disease (CD) and ulcerative colitis (UC),
        is a chronic, progressive inflammatory disease of the intestinal tract. The etiology of IBD
        is not well understood, but believed to result from a complex relationship between genetics,
        environment, and gut microbiome alterations, resulting in a self-perpetuating, abnormal
        mucosal immune response. The incidence of IBD is rising in developing and recently developed
        countries, highlighting the importance of environmental exposures in determining disease
        risk. Microplastics, defined as plastic particles <5 mm in size, are ubiquitous pollutants
        with unclear implications towards human health. Emerging studies indicate substantial
        disruption of intestinal immune function and a proinflammatory milieu due to microplastics.
        Therefore, identifying, and characterizing microplastics in stool samples of individuals with
        CD alongside alterations in microbiome and calprotectin, which are events that occur prior to
        CD onset, is the initial step in exploring the impact of microplastics on IBD. Moreover, CD
        affects women during their reproductive years and 25% become pregnant after diagnosis. Given
        that maternal IBD diagnosis is one of the major risks of future IBD in offspring, it is
        critical to better understand if babies born to mothers with IBD have higher content of
        microplastics or other toxins in the stools and whether these levels correlate with those of
        their mothers during pregnancy.
  observational model: Case-Control
  time perspective: Prospective
  measure: Microplastics quantification
  time frame: 1 year
  description: Measuring the concentration, size and shape distributions of microplastics in the stool samples of women with CD, healthy controls and any relatives (spouses and siblings of the infant).
  measure: Alpha and beta diversity
  time frame: 1 year
  description: Microbiome characterization - Bacterial DNA will be isolated from stool and sequenced to characterize the bacteria present in the microbiome. Alpha and beta diversity statistics will be reported.
  measure: Fecal calprotectin analysis
  time frame: 1 year
  description: Stool samples will be processed to quantify calprotectin levels which are routinely used to characterize inflammation.
  arm group label: Pregnant people with Crohns disease (Case)
  description: Arm 1 is pregnant people with Crohns disease who enroll with the infant that they are pregnant with at the time.
  arm group label: Pregnant people without Crohns disease (Control)
  description: Arm 2 is the control arm of pregnant people without Crohns disease and other inflammatory bowel diseases who enroll with the infant that they are pregnant with at the time.
  Stool, Saliva, Breast milk, Whole Blood (optional), Cord Blood (optional), Placenta
        (optional)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Manasi Agrawal, MD, MS
  role: Principal Investigator
  affiliation: Icahn School of Medicine at Mount Sinai
  last name: Mellissa Picker, BS
  phone: 212-659-6710
  phone ext: 86710
  email: mellissa.picker@mssm.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: https://labs.icahn.mssm.edu/peterlab/planet-study/
  description: You can find frequently asked questions, contact information and information about our lab at this link.
  responsible party type: Principal Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Manasi Agrawal
  investigator title: Assistant Professor of Medicine
  mesh term: Crohn Disease
  mesh term: Inflammatory Bowel Diseases
  mesh term: Inflammation
  sharing ipd: No
  ipd description: There is no blanket statement on IPD as some participants may opt out of data sharing in collaborations and the researchers will not be submitting data to any repositories.