<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/NCT02183974</url>
  </required_header>
  <id_info>
    <org_study_id>FNO-ENT-OME Restech</org_study_id>
    <nct_id>NCT02183974</nct_id>
  </id_info>
  <brief_title>Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion</brief_title>
  <official_title>Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Ostrava</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was detection of pepsin in effusion in children with OME using Peptest&#xD;
      as new quick and cheap method of detection and comparison results with results of other&#xD;
      studies in which pepsin was detected by more demanding methods. Such a type of study hasn't&#xD;
      been done so far.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME who&#xD;
      underwent adenoidectomy and myringotomy with insertion of ventilation tube were included in&#xD;
      the prospective study. OME was defined as effusion in the middle ear behind intact eardrum&#xD;
      longer than 3 months. Diagnosis was made on the basis of otomicroscopic findings, pneumatic&#xD;
      otoscopy, type B tympanometry and audiometry (in older cooperative children). Children with&#xD;
      no fluid in middle ear during myringotomy were revised as having tympanosclerosis and were&#xD;
      excluded from the study. Children with craniofacial abnormities (Down syndrome, Treacher&#xD;
      Collins syndrome, clefts etc.) were excluded from the study, as well. Demographic data and&#xD;
      symptoms of EER disease were provided by parents, who were particularly inquired regarding&#xD;
      the hoarseness, recurrent lower respiratory infection (bronchitis, pneumonia) and bronchial&#xD;
      asthma of their child.&#xD;
&#xD;
      Myringotomy using microscope was done in anterior inferior part of the tympanic membrane.&#xD;
      Type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid was collected by&#xD;
      special suction device with collecting bottle and ventilation tube was inserted in the&#xD;
      tympanic membrane. In case of bilateral OME, effusion was collected and analysed separately.&#xD;
      Specimen was first standardized. An amount of 0.1 ml of 10 % citric acid was added, specimen&#xD;
      was centrifuged for 10 minutes and subsequently original migration reagent was added.&#xD;
      Afterwards, specimen was examined using Peptest, which contains monoclonal antibodies&#xD;
      targeted against pepsin. Result of the Peptest was stated as positive (2 lines), negative (1&#xD;
      line) and invalid (no line). Peptest detection limit is 16ng/ml of pepsin. Statistical&#xD;
      analysis was done using MS Excel.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The frequency of the presence of pepsin in effusion in the middle ear as an indirect diagnostic method of extraesophageal reflux in children with otitis media with effusion</measure>
    <time_frame>2 years</time_frame>
    <description>The frequency of the presence of pepsin in effusion in the middle ear was detected using Peptest in children with OME</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Otitis Media With Effusion</condition>
  <arm_group>
    <arm_group_label>Peptest</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>44 children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME who underwent adenoidectomy and myringotomy with insertion of ventilation tube. Effusion was collected and analysed using Peptest, which contains monoclonal antibodies targeted against pepsin. Result of the Peptest was stated as positive (2 lines), negative (1 line) and invalid (no line).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Peptest</intervention_name>
    <arm_group_label>Peptest</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signing of the informed consent&#xD;
&#xD;
          -  children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with craniofacial abnormities (Down syndrome, Treacher Collins syndrome,&#xD;
             clefts etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martin Formánek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Ostrava</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava</city>
        <state>Moravian-Silesian Region</state>
        <zip>708 52</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czech Republic</country>
  </location_countries>
  <reference>
    <citation>Zelenik K, Matousek P, Urban O, Schwarz P, Starek I, Kominek P. Globus pharyngeus and extraesophageal reflux: simultaneous pH &lt;4.0 and pH &lt;5.0 analysis. Laryngoscope. 2010 Nov;120(11):2160-4. doi: 10.1002/lary.21147.</citation>
    <PMID>20938965</PMID>
  </reference>
  <reference>
    <citation>He Z, O'Reilly RC, Mehta D. Gastric pepsin in middle ear fluid of children with otitis media: clinical implications. Curr Allergy Asthma Rep. 2008 Nov;8(6):513-8. doi: 10.1007/s11882-008-0094-7.</citation>
    <PMID>18940143</PMID>
  </reference>
  <reference>
    <citation>O'Reilly RC, He Z, Bloedon E, Papsin B, Lundy L, Bolling L, Soundar S, Cook S, Reilly JS, Schmidt R, Deutsch ES, Barth P, Mehta DI. The role of extraesophageal reflux in otitis media in infants and children. Laryngoscope. 2008 Jul;118(7 Part 2 Suppl 116):1-9. doi: 10.1097/MLG.0b013e31817924a3.</citation>
    <PMID>18594333</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>July 2, 2014</last_update_submitted>
  <last_update_submitted_qc>July 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>otitis media with effusion</keyword>
  <keyword>Laryngopharyngeal Reflux</keyword>
  <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>
  <!-- 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/NCT02183974
org study id: FNO-ENT-OME Restech
nct id: NCT02183974
lead sponsor: 
has dmc: No
The aim of the study was detection of pepsin in effusion in children with OME using Peptest
      as new quick and cheap method of detection and comparison results with results of other
      studies in which pepsin was detected by more demanding methods. Such a type of study hasn't
      been done so far.
Children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME who
      underwent adenoidectomy and myringotomy with insertion of ventilation tube were included in
      the prospective study. OME was defined as effusion in the middle ear behind intact eardrum
      longer than 3 months. Diagnosis was made on the basis of otomicroscopic findings, pneumatic
      otoscopy, type B tympanometry and audiometry (in older cooperative children). Children with
      no fluid in middle ear during myringotomy were revised as having tympanosclerosis and were
      excluded from the study. Children with craniofacial abnormities (Down syndrome, Treacher
      Collins syndrome, clefts etc.) were excluded from the study, as well. Demographic data and
      symptoms of EER disease were provided by parents, who were particularly inquired regarding
      the hoarseness, recurrent lower respiratory infection (bronchitis, pneumonia) and bronchial
      asthma of their child.

      Myringotomy using microscope was done in anterior inferior part of the tympanic membrane.
      Type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid was collected by
      special suction device with collecting bottle and ventilation tube was inserted in the
      tympanic membrane. In case of bilateral OME, effusion was collected and analysed separately.
      Specimen was first standardized. An amount of 0.1 ml of 10 % citric acid was added, specimen
      was centrifuged for 10 minutes and subsequently original migration reagent was added.
      Afterwards, specimen was examined using Peptest, which contains monoclonal antibodies
      targeted against pepsin. Result of the Peptest was stated as positive (2 lines), negative (1
      line) and invalid (no line). Peptest detection limit is 16ng/ml of pepsin. Statistical
      analysis was done using MS Excel.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The frequency of the presence of pepsin in effusion in the middle ear as an indirect diagnostic method of extraesophageal reflux in children with otitis media with effusion
time frame: 2 years
description: The frequency of the presence of pepsin in effusion in the middle ear was detected using Peptest in children with OME
arm group label: Peptest
arm group type: Experimental
description: 44 children at the age between 1 to 7 years diagnosed with bilateral or unilateral OME who underwent adenoidectomy and myringotomy with insertion of ventilation tube. Effusion was collected and analysed using Peptest, which contains monoclonal antibodies targeted against pepsin. Result of the Peptest was stated as positive (2 lines), negative (1 line) and invalid (no line).
intervention type: Procedure
intervention name: Peptest
arm group label: Peptest
criteria: 
gender: All
minimum age: 1 Year
maximum age: 7 Years
healthy volunteers: No
last name: Martin Formánek, MD
role: Principal Investigator
affiliation: University Hospital Ostrava
facility: 
country: Czech Republic
citation: Zelenik K, Matousek P, Urban O, Schwarz P, Starek I, Kominek P. Globus pharyngeus and extraesophageal reflux: simultaneous pH <4.0 and pH <5.0 analysis. Laryngoscope. 2010 Nov;120(11):2160-4. doi: 10.1002/lary.21147.
PMID: 20938965
citation: He Z, O'Reilly RC, Mehta D. Gastric pepsin in middle ear fluid of children with otitis media: clinical implications. Curr Allergy Asthma Rep. 2008 Nov;8(6):513-8. doi: 10.1007/s11882-008-0094-7.
PMID: 18940143
citation: O'Reilly RC, He Z, Bloedon E, Papsin B, Lundy L, Bolling L, Soundar S, Cook S, Reilly JS, Schmidt R, Deutsch ES, Barth P, Mehta DI. The role of extraesophageal reflux in otitis media in infants and children. Laryngoscope. 2008 Jul;118(7 Part 2 Suppl 116):1-9. doi: 10.1097/MLG.0b013e31817924a3.
PMID: 18594333
responsible party type: Sponsor
mesh term: Otitis
mesh term: Otitis Media
mesh term: Otitis Media with Effusion