MMP and OME: Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | 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
Primary Outcome Measures
- Microscopic evaluation of the quality of the eardrum : normal or atrophic [before surgery]
Microscopic evaluation of the quality of the eardrum : normal or atrophic
Secondary Outcome Measures
- biochemical assay of the level of TIMP [1 day]
biochemical assay of the level of TIMP
- biochemical assay of the level of MMPs [1 day]
biochemical assay of the level of MMPs
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uhmontpellier | Montpellier | France | 34295 |
Sponsors and Collaborators
- University Hospital, Montpellier
- INM : institut des neurosciences Montpellier
Investigators
- Principal Investigator: Lylou Casteil Baume, ENT resident, University Hospital, Montpellier
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RECHMPL18_0306