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

Sponsor

University Hospital, Antwerp (Other)

Overall Status

Completed

CT.gov ID

NCT03109496

Collaborator

Universiteit Antwerpen (Other)

Enrollment

Location

25.3

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Otitis Media With Effusion Healthy	Other: Collection of body fluids/swabs

Study Design

Study Type:

Observational

Actual Enrollment :

82 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Apr 26, 2017

Actual Primary Completion Date :

Jun 6, 2019

Actual Study Completion Date :

Jun 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
OME Patients Suffer from chronic Otitis Media with Effusion (OME) for at least 3 months and undergo ventilation tube placement.	Other: Collection of body fluids/swabs Middle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant.
Healthy Control 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 Middle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant.

Arm

Intervention/Treatment

OME Patients

Suffer from chronic Otitis Media with Effusion (OME) for at least 3 months and undergo ventilation tube placement.

Other: Collection of body fluids/swabs

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

Healthy Control

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 45 Years

Sexes Eligible for Study:

All

Accepts 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.