Otitis Media With EffusionNCT02183961
Three Methods Used in the Diagnosis of EER in Children With OME
A study testing Restech, Peptest and Detection of pepsin in adenoid specimen in people with Otitis Media With Effusion and Laryngopharyngeal Reflux, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion (OME) using three different diagnostic methods and selection of the group of patients with severe EER who could potentially benefit from antireflux therapy. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Otitis Media With Effusion, Laryngopharyngeal Reflux
- What is being tested?
- Restech, Peptest and Detection of pepsin in adenoid specimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2012to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children with otitis media with effusion
- age 1-7 years
- signing of the informed consent
Who cannot join
- children with craniofacial abnormalities (Down syndrome, Treacher Collins syndrome, clefts etc.)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
About this study
Official title: Comparison of Three Methods Used in the Diagnosis of Extraesophageal Reflux in Children With Chronic Otitis Media With Effusion
Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion (OME) using three different diagnostic methods and selection of the group of patients with severe EER who could potentially benefit from antireflux therapy.
Read the detailed description
Children aged between 1 and 7 years diagnosed with bilateral or unilateral OME who underwent adenoidectomy and myringotomy with insertion of a ventilation tube were included in the prospective study. OME was defined as effusion in the middle ear behind an intact eardrum for 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 the middle ear during myringotomy were re-diagnosed as having tympanosclerosis and were excluded from the study. Children with craniofacial abnormalities (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 specifically asked about hoarseness, recurrent lower respiratory infections (bronchitis, pneumonia) and bronchial asthma in their child.
24 hour monitoring of oropharyngeal pH using the Restech system was performed before surgery. Parents were instructed to record the time their child spent eating, drinking and in a horizontal position directly to the device and manually to the diary. If there was any discrepancy, periods logged in the device were modified according to the diary. A standardized RYAN composite score was calculated automatically using the software supplied. Patients with pathological RYAN composite scores in the vertical (higher than 9.4) and/or horizontal (higher than 6.8) position were classified as having pathological EER. Severe EER was diagnosed when the RYAN composite score in the vertical or horizontal position was higher than 200.
Myringotomy using a microscope was done on the anterior inferior part of the tympanic membrane. The type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid was collected using a special suction device with a collecting bottle, and a ventilation tube was inserted in the tympanic membrane. In the case of bilateral OME, middle ear fluids were collected and analysed separately. The specimen was first standardized. 0.1 ml of 10% citric acid was added, the specimen was centrifuged for 10 minutes and subsequently the original migration reagent was added. Afterwards, the specimen was examined using Peptest, which contains monoclonal antibodies that target pepsin. The result of the Peptest was given as positive (2 lines), negative (1 line) or invalid (no line).
Then, adenoidectomy using a cold instrument was performed. A specimen of adenoids (5x5x5mm) from the area close to the torus tubarius was fixed in formaldehyde and immunohistochemically analysed at the Department of Pathology. Antibody P3635Rb-h (Uscnlife, USA, concentration 1:100) was used as the primary antibody. Antibody N-HistofineSimple Stain MAX PO (Nichirei Biosciences Inc.) was used as the secondary antibody.
Statistical analysis was done using MS Excel.
- Being tested
- Restech, Peptest, Detection of pepsin in adenoid specimen
- Keywords
- otitis media with effusion, peptest, restech, oropharyngeal pH monitoring, laryngopharyngeal reflux
- Medical subject headings
- Otitis Media with Effusion, Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestechOther
PeptestOther
Detection of pepsin in adenoid specimenOther
| Study group | Role | What they receive |
|---|---|---|
| Laryngopharyngeal reflux | Experimental | EER was detected using three methods: oropharyngeal pH was monitored for 24 hours using the Restech system; detection of pepsin in middle ear fluid obtained during myringotomy was done using Peptest, and detection of pepsin in adenoid specimen was done immunohistochemically using antibody P3635Rb-h. Receives: Other: Restech; Other: Peptest; Other: Detection of pepsin in adenoid specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of the extraesophageal reflux in children with otitis media with effusion measured with three different methods
Children between 1 to 7 years diagnosed with OME who underwent adenoidectomy and myringotomy with insertion of a ventilation tube were included in this prospective study. EER was detected using three methods: oropharyngeal pH was monitored for 24 hours using the Restech system; detection of pepsin in middle ear fluid obtained during myringotomy was done using Peptest, and detection of pepsin in an adenoid specimen was done immunohistochemically using antibody P3635Rb-h.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Formánek, MD, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183961
- Sponsor's protocol ID
- FNO-ENT-EER Peptest Restech
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18594333Zelenik 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.
PubMed 20938965Jiang A, Liang M, Su Z, Chai L, Lei W, Wang Z, Wang A, Wen W, Chen M. Immunohistochemical detection of pepsin in laryngeal mucosa for diagnosing laryngopharyngeal reflux. Laryngoscope. 2011 Jul;121(7):1426-30. doi: 10.1002/lary.21809. Epub 2011 Jun 6.
PubMed 21647907Wiener GJ, Tsukashima R, Kelly C, Wolf E, Schmeltzer M, Bankert C, Fisk L, Vaezi M. Oropharyngeal pH monitoring for the detection of liquid and aerosolized supraesophageal gastric reflux. J Voice. 2009 Jul;23(4):498-504. doi: 10.1016/j.jvoice.2007.12.005. Epub 2008 May 12.
PubMed 18468849
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Methods Used in the Diagnosis of Extraesophageal Reflux in Children With Chronic Otitis Media With Effusion
- ClinicalTrials.gov ID
- NCT02183961
- Acronym / sponsor ID
- FNO-ENT-EER Peptest Restech
- Keywords
- otitis media with effusion, peptest, restech, oropharyngeal pH monitoring, laryngopharyngeal reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion (OME) using three different diagnostic methods and selection of the group of patients with severe EER who could potentially benefit from antireflux therapy.
Detailed description
Children aged between 1 and 7 years diagnosed with bilateral or unilateral OME who underwent adenoidectomy and myringotomy with insertion of a ventilation tube were included in the prospective study. OME was defined as effusion in the middle ear behind an intact eardrum for 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 the middle ear during myringotomy were re-diagnosed as having tympanosclerosis and were excluded from the study. Children with craniofacial abnormalities (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 specifically asked about hoarseness, recurrent lower respiratory infections (bronchitis, pneumonia) and bronchial asthma in their child.
24 hour monitoring of oropharyngeal pH using the Restech system was performed before surgery. Parents were instructed to record the time their child spent eating, drinking and in a horizontal position directly to the device and manually to the diary. If there was any discrepancy, periods logged in the device were modified according to the diary. A standardized RYAN composite score was calculated automatically using the software supplied. Patients with pathological RYAN composite scores in the vertical (higher than 9.4) and/or horizontal (higher than 6.8) position were classified as having pathological EER. Severe EER was diagnosed when the RYAN composite score in the vertical or horizontal position was higher than 200.
Myringotomy using a microscope was done on the anterior inferior part of the tympanic membrane. The type of middle ear effusion (fluid, mucous) was registered. Middle ear fluid was collected using a special suction device with a collecting bottle, and a ventilation tube was inserted in the tympanic membrane. In the case of bilateral OME, middle ear fluids were collected and analysed separately. The specimen was first standardized. 0.1 ml of 10% citric acid was added, the specimen was centrifuged for 10 minutes and subsequently the original migration reagent was added. Afterwards, the specimen was examined using Peptest, which contains monoclonal antibodies that target pepsin. The result of the Peptest was given as positive (2 lines), negative (1 line) or invalid (no line).
Then, adenoidectomy using a cold instrument was performed. A specimen of adenoids (5x5x5mm) from the area close to the torus tubarius was fixed in formaldehyde and immunohistochemically analysed at the Department of Pathology. Antibody P3635Rb-h (Uscnlife, USA, concentration 1:100) was used as the primary antibody. Antibody N-HistofineSimple Stain MAX PO (Nichirei Biosciences Inc.) was used as the secondary antibody.
Statistical analysis was done using MS Excel.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laryngopharyngeal reflux | Experimental | Other: Restech, Other: Peptest, Other: Detection of pepsin in adenoid specimenEER was detected using three methods: oropharyngeal pH was monitored for 24 hours using the Restech system; detection of pepsin in middle ear fluid obtained during myringotomy was done using Peptest, and detection of pepsin in adenoid specimen was done immunohistochemically using antibody P3635Rb-h. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children with otitis media with effusion
- age 1-7 years
- signing of the informed consent
Key exclusion criteria (1 listed)
- children with craniofacial abnormalities (Down syndrome, Treacher Collins syndrome, clefts etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restech | Other | Laryngopharyngeal reflux |
| Peptest | Other | Laryngopharyngeal reflux |
| Detection of pepsin in adenoid specimen | Other | Laryngopharyngeal reflux |
Primary outcome
The frequency of the extraesophageal reflux in children with otitis media with effusion measured with three different methods
Time frame: 2 years
Children between 1 to 7 years diagnosed with OME who underwent adenoidectomy and myringotomy with insertion of a ventilation tube were included in this prospective study. EER was detected using three methods: oropharyngeal pH was monitored for 24 hours using the Restech system; detection of pepsin in middle ear fluid obtained during myringotomy was done using Peptest, and detection of pepsin in an adenoid specimen was done immunohistochemically using antibody P3635Rb-h.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Background: PubMed 18594333O'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.
- Background: PubMed 20938965Zelenik 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.
- Background: PubMed 21647907Jiang A, Liang M, Su Z, Chai L, Lei W, Wang Z, Wang A, Wen W, Chen M. Immunohistochemical detection of pepsin in laryngeal mucosa for diagnosing laryngopharyngeal reflux. Laryngoscope. 2011 Jul;121(7):1426-30. doi: 10.1002/lary.21809. Epub 2011 Jun 6.
- Background: PubMed 18468849Wiener GJ, Tsukashima R, Kelly C, Wolf E, Schmeltzer M, Bankert C, Fisk L, Vaezi M. Oropharyngeal pH monitoring for the detection of liquid and aerosolized supraesophageal gastric reflux. J Voice. 2009 Jul;23(4):498-504. doi: 10.1016/j.jvoice.2007.12.005. Epub 2008 May 12.
Related trials for Otitis Media With Effusion
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Not yet recruiting
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
Recruiting
SWIR Otoscopy Study
Otitis Media, Otitis Media Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Formánek, MD principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restech, Peptest and Detection of pepsin in adenoid specimen in people with Otitis Media With Effusion and Laryngopharyngeal Reflux, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of the extraesophageal reflux in children with otitis media with effusion measured with three different methods (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02183961, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2014.