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Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum (MMP and OME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03611842
Recruitment Status : Completed
First Posted : August 2, 2018
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
INM : institut des neurosciences Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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Brief Summary:

Metalloproteinases (MMPs) constitute a family of endopeptidases that cleaves the extracellular matrix as collagen included in the eardrum. Activity of MMP has been shown in some otitis media with effusion (OME) fluids. These enzymes could be directly linked to the prosnostic of OME as it may damage the eardrum and leads to tympanic atrophy.

The main goal of the study is to find out the correlation between activity of MMPs and tympanic atrophy. The investigator will also study if there is any clinical predictive factors in relation to the level of MMPs.


Condition or disease Intervention/treatment
Otitis Media With Effusion Other: preservation of mucosal otitis media

Detailed Description:

The investigator will include 35 children under 12 years old with OME and who need tympanostomy or tube placement under general anesthesia. Middle ear effusion will be collected, divided in two and frozen.

The investigator will perform ELISA tests to measure the level of MMP2 MMP9 MMP7 et TIMP2 (inhibitor of MMPs). The investigator want to compare the level of MMPs between healthy eardrum and atrophic membrane.

Clinical data will be collected such as age, gender, chronicity of the OME, quality of the eardrum and middle ear effusion type to see if there is any difference when MMPs level is higher.

Study Design
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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study of the Expression of MMPs (Metalloproteinase Matricial) in OME (Otitis Media With Effusion) in Children Under Twelve Years Old With Atrophy of the Eardrum
Actual Study Start Date : September 30, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy eardrum
OME (otitis media with effusion)with normal tympanic membrane
 Other: preservation of mucosal otitis media
Suction of the middle ear fluid and conservation of the fluid to be collected instead of thrown away into children Healthy eardrum and Atrophic eardrum
Atrophic eardrum
OME (otitis media with effusion) with atrophic membrane : thinning of the membrane, retraction pocket
 Other: preservation of mucosal otitis media
Suction of the middle ear fluid and conservation of the fluid to be collected instead of thrown away into children Healthy eardrum and Atrophic eardrum


Outcome Measures
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Primary Outcome Measures :
  1. Microscopic evaluation of the quality of the eardrum : normal or atrophic [ Time Frame: before surgery ]
    Microscopic evaluation of the quality of the eardrum : normal or atrophic


Secondary Outcome Measures :
  1. biochemical assay of the level of TIMP [ Time Frame: 1 day ]
    biochemical assay of the level of TIMP

  2. biochemical assay of the level of MMPs [ Time Frame: 1 day ]
    biochemical assay of the level of MMPs


Biospecimen Retention:   Samples With DNA
Middle ear effusion fluids

Eligibility Criteria
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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children under the age of twelve with OME and surgical indication for myringostomy of tube placement
Criteria

Inclusion Criteria:

- every children under 12 yo operated on in Gui de Chauliac Hospital

Exclusion criteria:

- when effusion is not possible to collect (too thick or amount of fluid not enough)

Collection of both MEE on each ear when OME is bilateral. We will perform the tests on only one ear. The other one will be kept in case of technical issue. A random draw will establish which ear will be tested.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611842


Locations
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France
Uhmontpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
INM : institut des neurosciences Montpellier
Investigators
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Principal Investigator: Lylou Casteil Baume, ENT resident University Hospital, Montpellier
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03611842    
Other Study ID Numbers: RECHMPL18_0306
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Atrophy
 Pathological Conditions, Anatomical
Ear Diseases
Otorhinolaryngologic Diseases