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Completed

NCT Number: NCT03109496

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

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.

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Ear Diseases Healthy Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

1 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of body fluids/swabs

Other

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

Primary outcomes

  1. Microbiota differences between the healthy and diseased URT and middle ear space

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • Universiteit Antwerpen

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 12, 2017
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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