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

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

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.

Study Overview

• Status: Completed
• Conditions: Otitis Media With Effusion
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children under the age of twelve with OME and surgical indication for myringostomy of tube placement

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
biochemical assay of the level of TIMP	biochemical assay of the level of TIMP	1 day
biochemical assay of the level of MMPs	biochemical assay of the level of MMPs	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: INM : institut des neurosciences Montpellier
• Investigators: Principal Investigator: Lylou Casteil Baume, ENT resident, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 30, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Pathological Conditions, Anatomical; Otitis; Atrophy; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: RECHMPL18_0306

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No