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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03109496

Enrollment

Registered

2017-04-12

Start date

2017-04-26

Completion date

2019-06-06

Last updated

2020-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Otitis Media With Effusion

Keywords

OME, Otitis Media with Effusion, Microbiota, Microbiome, URT, Upper Respiratory Tract, Healthy URT microbiota

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.

Interventions

OTHERCollection of body fluids/swabs

Middle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant.

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026