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

Completed

• Conditions: Otitis Media With Effusion; Healthy
• Interventions: Other: Collection of body fluids/swabs

• Registration Number: NCT03109496
• Lead Sponsor: University Hospital, Antwerp

Brief Summary

This study analyses which bacteria are present in the middle ear space and adjacent upper respiratory tract niches in healthy people and in patients suffering from chronic otitis media with effusion (OME; glue ear). The aim is to identify and isolate bacteria that are more common and more abundant in healthy people and to evaluate their potential to protect against bacteria commonly involved in OME and other upper respiratory tract infections.

To this end, samples will be collected from both groups (healthy vs OME) and analysed through sequencing of the bacterial 16S gene. In addition, samples obtained from healthy participants will be cultivated to isolate bacteria of interest.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Study Start: 2017-04-26
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OME Patients	Collection of body fluids/swabs	Suffer from chronic Otitis Media with Effusion (OME) for at least 3 months and undergo ventilation tube placement.
Healthy Control	Collection of body fluids/swabs	Undergo surgery that gives access to the middle ear space (e.g. cochlear implant surgery) or adenoids, in absence of upper respiratory tract infections.

Primary Outcome Measures

Name	Time	Method
Microbiota differences between the healthy and diseased URT and middle ear space	Appr. 4 years	The composition of the bacterial community will be determined through sequencing of the bacterial 16S gene and compared between the participant groups. Species over-represented in healthy participants will be investigated further.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium