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<docDscr>
  <citation>
    <titlStmt>
      <titl>Observational study on the diagnostic evaluation of the intestinal microbiota of French people infected with the Coronavirus</titl>
      <IDNo>FRESH-PEF73614-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="LUXIA SCIENTIFIC" role="">Alessandra CERVINO</producer>
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      <version></version>
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<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Observational study on the diagnostic evaluation of the intestinal microbiota of French people infected with the Coronavirus            </titl>
      <altTitl>
                    EDIFICE                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73614-en            </IDNo>
      <IDNo agency="PEF">
                    73614                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73614                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Alessandra CERVINO                                                                                </AuthEnty>
      <AuthEnty affiliation="LUXIA SCIENTIFIC">
        <ExtLink title="SIREN" URI="790719132" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            LUXIA SCIENTIFIC                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="CLINIQUE SAINT JEAN-L'ERMITAGE" email="guy.marti@doctocare.com">
                    Guy;MARTI
                                            <ExtLink title="SIREN" URI="304100332" role="organisation id"/>
                                    </contact>
      <contact affiliation="LUXIA SCIENTIFIC" email="a.cervino@pileje.com">
                    Alessandra;CERVINO
                                            <ExtLink title="SIREN" URI="790719132" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    intestinal microbiota</keyword>
      <topcClas vocab="health theme">
                        Clinical immunology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7a3cf568-46ba-4840-be8f-f22fc030139f"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D000486"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Infectious disease medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D055552"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Internal medicine                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/0d45044a-74d5-4bd7-b920-b92af3388576"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/f0844378-9f30-4873-b19b-5bff8c184a36"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D007388"/>
                                                </topcClas>
      <topcClas vocab="health theme">
                        Gastroenterology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/a3898340-a42d-4f5e-a822-1de204a9a867"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D005762"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        COVID-19                                            </topcClas>
    </subject>
    <abstract contentType="purpose">Validate the hypothesis for a relationship between the loss of diversity of the intestinal microbiota and screening positive for COVID-19, by comparing hospitalised COVID-19 positive patients with an exposed French population represented by hospital medical and paramedical personnel</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date=""/>
      <collDate event="end" date=""/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">General population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe clusion="I">COVID-19 positive patients: hospitalised patients diagnosed with COVID-19 in one of the  investigating sites, and able to provide a stool sample Exposed subjects: Medical and paramedical personnel working at one of the  investigating sites, having been in direct contact with the patients. Aged between 18 and 95 years Subjects able to read the French-language study information leaflet Patients with social cover                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
    <qualityStatement>
      <otherQualityStatement>ISO13485</otherQualityStatement>
    </qualityStatement>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Health event/mortality</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>160</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
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