<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/NCT04418622</url>
  </required_header>
  <id_info>
    <org_study_id>METEL-RC (29BRC19.0162)</org_study_id>
    <nct_id>NCT04418622</nct_id>
  </id_info>
  <brief_title>Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis</brief_title>
  <acronym>METEL-RC</acronym>
  <official_title>Evolution of the Endonasal Microbiota After Endoscopic and Local Treatment or Local Treatment Alone in Patients With Chronic Rhinosinusitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <brief_summary>
    <textblock>
      Chronic rhinosinusitis (CRS) is defined according to the French society of&#xD;
      otorhinolaryngology as chronic non-mechanical damage to the nasal structures, excluding&#xD;
      infectious damage to the sinus structures. The duration of the chronic impairment must be at&#xD;
      least 12 consecutive weeks. It causes many symptoms such as rhinorrhea, nasal blockage and&#xD;
      anosmia. It is a poorly understood pathology that affects a large part of the population. Its&#xD;
      prevalence has increased significantly over the past 30 years. It affects about 11% of the&#xD;
      population in Europe. It has become one of ten high-cost medical conditions for employers.&#xD;
      Initially, it was accepted that CRS was due to chronic nasal infection. It is very&#xD;
      debilitating for patients leading to a major consultation with practitioners (general&#xD;
      practitioners and ENT specialists). Many treatments are used such as nose washes, nasal or&#xD;
      oral corticosteroids, antibiotic therapy or even surgical management is possible. Thèses&#xD;
      treatments allow an improvement in the symptomatology but no treatment allows a stable result&#xD;
      over time, making long-term treatments essential.&#xD;
&#xD;
      Today, it is recognized that CRS has a multifactorial etiology including inflammatory&#xD;
      processes, hyperresponsiveness of the nasal mucosa and abnormalities in immune phenomena. The&#xD;
      endonasal microbiota plays a role in these processes. Germs like Staphylococcus aureus and&#xD;
      Pseudomonas aeruginosa were identified as pathogens in CRS in the first studies with&#xD;
      bacterial cultures. Thanks to the 16S ribosomal RNA sequencing technique, recent studies have&#xD;
      demonstrated a modification in the diversity and abundance of the microbiota in patients with&#xD;
      CRS compared to healthy subjects, notably with a modification of the germs of the firmicutes&#xD;
      group. .&#xD;
&#xD;
      Few studies have studied the modification of the microbiota with the treatment of CRS today.&#xD;
      However, local treatments based on nosewashing with physiological saline associated with&#xD;
      local corticosteroids and endoscopic treatments lead to an improvement in the symptomatology&#xD;
      for patients suffering from CRS. This study will describe the modification of endonasal&#xD;
      microbiota in différent conditions, such medical and surgical treatments, that usually&#xD;
      improve patients symptomatology.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 21, 2020</start_date>
  <completion_date type="Actual">November 15, 2021</completion_date>
  <primary_completion_date type="Actual">November 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>description of biodiversity of the microbiota</measure>
    <time_frame>six month</time_frame>
    <description>Shannon index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>richness of samples</measure>
    <time_frame>six month</time_frame>
    <description>number of OTU (operational taxonomic unit)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>patient quality of life</measure>
    <time_frame>six month</time_frame>
    <description>specific questionnaire Sino-nasal Outcome Test (SNOT-22). minimum 0 maximum 110. The higher the score the greater the impact of the symptoms on quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rhinosinusal inflammation</measure>
    <time_frame>six month</time_frame>
    <description>lund kennedy score. Minimum 0. maximum 10. the higher the score the greater the signs of chronic rhinosinusitis.</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Chronic Sinusitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients without chronic rhinosinusitis who undergo a nasal surgery and patients with&#xD;
        chronic rhinosinusitis who undergo a medical or surgical treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients without chronic rhinosinusitis who undergo a nasal surgery&#xD;
&#xD;
          -  patients with chronic rhinosinusitis who undergo a medical or surgical treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  minor patients&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  patients undergoing antibiotic therapy in the month preceding the start of the study&#xD;
&#xD;
          -  patients with immunosuppression&#xD;
&#xD;
          -  ENT cancer or other cancer in progress&#xD;
&#xD;
          -  primary ciliary dyskinesia or cystic fibrosis&#xD;
&#xD;
          -  Systemic vasculitis (Wegener, Gougerot-Sjögren ...)&#xD;
&#xD;
          -  Refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>November 29, 2021</last_update_submitted>
  <last_update_submitted_qc>November 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2021</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>Sinusitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected data that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available after the publication of result and ending five years following the last visit of the last patient</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the international committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
  </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/NCT04418622
org study id: METEL-RC (29BRC19.0162)
nct id: NCT04418622
lead sponsor: 
Chronic rhinosinusitis (CRS) is defined according to the French society of
      otorhinolaryngology as chronic non-mechanical damage to the nasal structures, excluding
      infectious damage to the sinus structures. The duration of the chronic impairment must be at
      least 12 consecutive weeks. It causes many symptoms such as rhinorrhea, nasal blockage and
      anosmia. It is a poorly understood pathology that affects a large part of the population. Its
      prevalence has increased significantly over the past 30 years. It affects about 11% of the
      population in Europe. It has become one of ten high-cost medical conditions for employers.
      Initially, it was accepted that CRS was due to chronic nasal infection. It is very
      debilitating for patients leading to a major consultation with practitioners (general
      practitioners and ENT specialists). Many treatments are used such as nose washes, nasal or
      oral corticosteroids, antibiotic therapy or even surgical management is possible. Thèses
      treatments allow an improvement in the symptomatology but no treatment allows a stable result
      over time, making long-term treatments essential.

      Today, it is recognized that CRS has a multifactorial etiology including inflammatory
      processes, hyperresponsiveness of the nasal mucosa and abnormalities in immune phenomena. The
      endonasal microbiota plays a role in these processes. Germs like Staphylococcus aureus and
      Pseudomonas aeruginosa were identified as pathogens in CRS in the first studies with
      bacterial cultures. Thanks to the 16S ribosomal RNA sequencing technique, recent studies have
      demonstrated a modification in the diversity and abundance of the microbiota in patients with
      CRS compared to healthy subjects, notably with a modification of the germs of the firmicutes
      group. .

      Few studies have studied the modification of the microbiota with the treatment of CRS today.
      However, local treatments based on nosewashing with physiological saline associated with
      local corticosteroids and endoscopic treatments lead to an improvement in the symptomatology
      for patients suffering from CRS. This study will describe the modification of endonasal
      microbiota in différent conditions, such medical and surgical treatments, that usually
      improve patients symptomatology.
observational model: Ecologic or Community
time perspective: Prospective
measure: description of biodiversity of the microbiota
time frame: six month
description: Shannon index
measure: richness of samples
time frame: six month
description: number of OTU (operational taxonomic unit)
measure: patient quality of life
time frame: six month
description: specific questionnaire Sino-nasal Outcome Test (SNOT-22). minimum 0 maximum 110. The higher the score the greater the impact of the symptoms on quality of life.
measure: rhinosinusal inflammation
time frame: six month
description: lund kennedy score. Minimum 0. maximum 10. the higher the score the greater the signs of chronic rhinosinusitis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Sinusitis
sharing ipd: Yes
ipd description: All collected data that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: Data will be available after the publication of result and ending five years following the last visit of the last patient
ipd access criteria: Data access requests will be reviewed by the international committee of Brest UH. Requestors will be required to sign and complete a data access agreement.