Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum

Otitis Media With Effusion Clinical Trial

— MMP and OME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611842
• Other study ID #: RECHMPL18_0306
• Status: Completed
• Start date: September 30, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: July 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 30, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrophy
• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

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

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	INM : institut des neurosciences Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microscopic evaluation of the quality of the eardrum : normal or atrophic	Microscopic evaluation of the quality of the eardrum : normal or atrophic	before surgery
Secondary	biochemical assay of the level of TIMP	biochemical assay of the level of TIMP	1 day
Secondary	biochemical assay of the level of MMPs	biochemical assay of the level of MMPs	1 day