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Completed

NCT Number: NCT03611842

Study of the Expression of MMPs in OME in Children 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.

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

preservation of mucosal otitis media

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • INM : institut des neurosciences Montpellier

Registry information

Official study 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

Acronym: MMP and OME

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
Apr 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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