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

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ClinicalTrials.gov Identifier: NCT03109496
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : December 26, 2017
Sponsor:
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
Estimated Enrollment : 200 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
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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.



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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 Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Olivier M Vanderveken, MD, PhD    + 32 3 821 33 84    Olivier.Vanderveken@uza.be   
Contact: Jennifer Jörissen, MSc    +32 3 265 3217    jennifer.jorissen@uantwerpen.be   
Principal Investigator: Olivier M Vanderveken, MD, PhD         
Sponsors and Collaborators
University Hospital, Antwerp

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Responsible Party: Ethisch Comité UZA, prof. dr. Olivier Vanderveken, MD, PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03109496     History of Changes
Other Study ID Numbers: B300201731724
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
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