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

NCT03109496 | Completed

• 1 other identifier: B300201731724
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media With Effusion; Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Collection of body fluids/swabs OTHER

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

Healthy Control; OME Patients

Eligibility Criteria

• Age: 1 Year - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

100 healthy participants vs 100 OME patients.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

• Jorissen J, van den Broek MFL, De Boeck I, Van Beeck W, Wittouck S, Boudewyns A, Van de Heyning P, Topsakal V, Van Rompaey V, Wouters I, Van Heirstraeten L, Van Damme P, Malhotra-Kumar S, Theeten H, Vanderveken OM, Lebeer S. Case-Control Microbiome Study of Chronic Otitis Media with Effusion in Children Points at Streptococcus salivarius as a Pathobiont-Inhibiting Species. mSystems. 2021 Apr 20;6(2):e00056-21. doi: 10.1128/mSystems.00056-21.

  PMID: 33879499 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples with extracted DNA (extraction kit targets bacterial DNA) Original samples in glycerol (100 µL) of otitis media patients (for potential future isolation of otitis media associated bacteria)

MeSH Terms

Conditions

Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. Olivier Vanderveken, MD, PhD

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: April 26, 2017
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)