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

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Upper Respiratory Tract Microbiota and the Potential of Probiotics for the Treatment of Chronic Otitis Media With Effusion.

Conditions
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Otitis Media With Effusion, Healthy

Intervention / Treatment
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* Other: Collection of body fluids/swabs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OME Patients<br>Suffer from chronic Otitis Media with Effusion (OME) for at least 3 months and undergo ventilation tube placement. | Other: Collection of body fluids/swabs<br>* Middle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant.<br>|
| Healthy Control<br>Undergo surgery that gives access to the middle ear space (e.g. cochlear implant surgery) or adenoids, in absence of upper respiratory tract infections. | Other: Collection of body fluids/swabs<br>* Middle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiota differences between the healthy and diseased URT and middle ear space | 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. | Appr. 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OME, Otitis Media with Effusion, Microbiota, Microbiome, URT, Upper Respiratory Tract, Healthy URT microbiota