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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109496
• Other study ID #: B300201731724
• Status: Completed
• Start date: April 26, 2017
• Est. completion date: June 6, 2019

Study information

• Verified date: April 2020
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Other:
• Collection of body fluids/swabs
Middle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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