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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03109496
Recruitment Status : Completed
First Posted : April 12, 2017
Last Update Posted : April 8, 2020
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Ethisch Comité, UZA, University Hospital, Antwerp

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
Otitis Media With Effusion Healthy Other: Collection of body fluids/swabs

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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 : April 26, 2017
Actual Primary Completion Date : June 6, 2019
Actual Study Completion Date : June 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Group/Cohort 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.




Primary Outcome Measures :
  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.


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)


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
100 healthy participants vs 100 OME patients.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109496


Locations
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Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
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Responsible Party: Ethisch Comité, UZA, prof. dr. Olivier Vanderveken, MD, PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03109496    
Other Study ID Numbers: B300201731724
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ethisch Comité, UZA, University Hospital, Antwerp:
OME
Otitis Media with Effusion
Microbiota
Microbiome
URT
Upper Respiratory Tract
Healthy URT microbiota
Additional relevant MeSH terms:
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Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases