The URT and Middle Ear Microbiota in Health and During Chronic OME

Plain-language summary

This is an observational study of the upper respiratory tract and middle ear microbiota in healthy people and in patients with chronic otitis media with effusion (OME). It was open to control patients undergoing middle ear or adenoid surgery and OME patients receiving ventilation tubes. It was conducted as an observational study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

University Hospital, Antwerp

Intervention

Collection of body fluids/swabs

Start date

4/26/2017

Estimated completion

6/6/2019

Countries

Belgium

Related genes

Locations

• Edegem, Belgium

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Controls: undergo a surgery that gives access to the middle ear space (at least 30 participants; e.g. cochlear implant recipients) or the adenoids.
* OME patients: have fluid accumulation in the middle ear space for 3+ months and receive ventilation tubes. May also undergo adenoidectomy.

Exclusion Criteria:

* Acute upper respiratory tract infections (including acute otitis media)
* Chronic upper respiratory tract infections (except OME in patient group)
* URT malformations (e.g. as seen in people with Down Syndrome or cleft palate)
* Cystic fibrosis
* Autoimmune diseases or immunodeficiency
* Pregnancy
* Use of antibiotics or steroids 1 week before surgery