<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/NCT03277820</url>
  </required_header>
  <id_info>
    <org_study_id>B300201731908</org_study_id>
    <nct_id>NCT03277820</nct_id>
  </id_info>
  <brief_title>Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion</brief_title>
  <official_title>Effect of Probiotics on Microbiome of Adenoid Tissue and Middle Ear Fluid of Children With Otitis Media With Effusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Antwerp</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 aim of this study is to investigate whether the microbiota in the upper respiratory tract&#xD;
      (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is&#xD;
      changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid&#xD;
      and tissue will be isolated via commercially available DNA extraction kits, followed by&#xD;
      Illumina MiSeq sequencing in order to identify the bacterial species present in these&#xD;
      samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">April 30, 2021</completion_date>
  <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Investigator does not know which subjects administered probiotics</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Microbiome differences</measure>
    <time_frame>4 years</time_frame>
    <description>After Illumina MiSeq sequencing, bio-informatic tools will be used to cluster bacteria into operational taxonomic units (OTUs). Based on these OTUs, we will compare the composition of the bacteria in the sampled niches and compare this composition between patient with and without intake of probiotics. We will specifically screen for OTUs that are over- or underrepresented in both populations. Furthermore, special attention will go to screen for the typical nasopharyngeal pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis... and also to beneficial microbes such as lactic acid bacteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Differences in absolute concentration of otitis media pathogens</measure>
    <time_frame>4 years</time_frame>
    <description>After DNA extraction of the biological samples, the absolute concentration of the administered probiotics and otitis media pathogens will be monitored via qPCR. This will give information about the capacity of the probiotics to colonise the nasopharynx and to alter the concentration of pathogens.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Otitis Media With Effusion</condition>
  <condition>Probiotics</condition>
  <condition>Adenoid Vegetations</condition>
  <arm_group>
    <arm_group_label>Probiotic group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intake of Probactiol Mini</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probactiol Mini</intervention_name>
    <description>6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)</description>
    <arm_group_label>Probiotic group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with otitis media with effusion&#xD;
&#xD;
          -  children with adenoid hypertrophy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no patients with trisomy 21&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>ethisch.comite@uza.be</investigator_full_name>
    <investigator_title>prof. dr. An Boudewyns, MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Otitis</mesh_term>
    <mesh_term>Otitis Media</mesh_term>
    <mesh_term>Otitis Media with Effusion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03277820
org study id: B300201731908
nct id: NCT03277820
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate whether the microbiota in the upper respiratory tract
      (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is
      changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid
      and tissue will be isolated via commercially available DNA extraction kits, followed by
      Illumina MiSeq sequencing in order to identify the bacterial species present in these
      samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Investigator)
masking description: Investigator does not know which subjects administered probiotics
measure: Microbiome differences
time frame: 4 years
description: After Illumina MiSeq sequencing, bio-informatic tools will be used to cluster bacteria into operational taxonomic units (OTUs). Based on these OTUs, we will compare the composition of the bacteria in the sampled niches and compare this composition between patient with and without intake of probiotics. We will specifically screen for OTUs that are over- or underrepresented in both populations. Furthermore, special attention will go to screen for the typical nasopharyngeal pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis... and also to beneficial microbes such as lactic acid bacteria.
measure: Differences in absolute concentration of otitis media pathogens
time frame: 4 years
description: After DNA extraction of the biological samples, the absolute concentration of the administered probiotics and otitis media pathogens will be monitored via qPCR. This will give information about the capacity of the probiotics to colonise the nasopharynx and to alter the concentration of pathogens.
arm group label: Probiotic group
arm group type: Experimental
description: Intake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.
arm group label: Control group
arm group type: No Intervention
description: No intake of Probactiol Mini
intervention type: Dietary Supplement
intervention name: Probactiol Mini
description: 6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
arm group label: Probiotic group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 12 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: ethisch.comite@uza.be
investigator title: prof. dr. An Boudewyns, MD, PhD
mesh term: Otitis
mesh term: Otitis Media
mesh term: Otitis Media with Effusion
sharing ipd: No