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

NCT ID: NCT03109496

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-26
• Study Completion Date: 2019-06-06

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

OME Patients

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

Collection of body fluids/swabs

Intervention Type: OTHER

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.

Collection of body fluids/swabs

Intervention Type: OTHER

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

Interventions

Collection of body fluids/swabs

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Ethisch Comité, UZA

prof. dr. Olivier Vanderveken, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 33879499 (View on PubMed)

Other Identifiers

B300201731724

Identifier Type: -

Identifier Source: org_study_id