Otitis Media With EffusionNCT03109496
The URT and Middle Ear Microbiota in Health and During Chronic OME
An observational study of Otitis Media With Effusion and Healthy, run by University Hospital, Antwerp at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 1 year to 45 years
- Conditions the study is for
- Otitis Media With Effusion, Healthy
- What is being tested?
- Collection of body fluids/swabs
- How many people
- 82 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Apr 2017to 6 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 100 healthy participants vs 100 OME patients.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Upper Respiratory Tract Microbiota and the Potential of Probiotics for the Treatment of Chronic Otitis Media With Effusion.
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
- Being tested
- Collection of body fluids/swabs
- Keywords
- OME, Otitis Media with Effusion, Microbiota, Microbiome, URT, Upper Respiratory Tract, Healthy URT microbiota
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of body fluids/swabsOther
Middle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant.
| Study group | Role | What they receive |
|---|---|---|
| OME Patients | Suffer from chronic Otitis Media with Effusion (OME) for at least 3 months and undergo ventilation tube placement. Receives: Other: Collection of body fluids/swabs | |
| 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. Receives: Other: Collection of body fluids/swabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Appr. 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start26 Apr 2017
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Ethisch Comité, UZA, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109496
- Sponsor's protocol ID
- B300201731724
- Status last verified
- Apr 2020
- First submitted
- 6 Apr 2017
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33879499
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Upper Respiratory Tract Microbiota and the Potential of Probiotics for the Treatment of Chronic Otitis Media With Effusion.
- ClinicalTrials.gov ID
- NCT03109496
- Acronym / sponsor ID
- B300201731724
- Conditions
- Otitis Media With Effusion, Healthy
- Keywords
- OME, Otitis Media with Effusion, Microbiota, Microbiome, URT, Upper Respiratory Tract, Healthy URT microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OME Patients | – | Other: Collection of body fluids/swabsSuffer from chronic Otitis Media with Effusion (OME) for at least 3 months and undergo ventilation tube placement. |
| Healthy Control | – | Other: Collection of body fluids/swabsUndergo surgery that gives access to the middle ear space (e.g. cochlear implant surgery) or adenoids, in absence of upper respiratory tract infections. |
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 100 healthy participants vs 100 OME patients.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of body fluids/swabsMiddle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant. | Other | Healthy Control, OME Patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Derived from this study: PubMed 33879499Jorissen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media With Effusion and Healthy, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota differences between the healthy and diseased URT and middle ear space (time frame: Appr. 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03109496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.