Microbiota Upper Respiratory TractProCureNCT02933983
Microbiota Upper Respiratory Tract
An observational study of Microbiota Upper Respiratory Tract, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The aim of this study is to investigate whether the microbiota in the upper respiratory tract (URT) (nose, nasopharynx and sinuses) of chronic rhinosinusitis (CRS) patients is disturbed compared to healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Microbiota Upper Respiratory Tract
- How many people
- 325 participants
- Where
- 1 siteBelgium
- Study dates
- May 2015to 24 Aug 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population involves both healthy individuals and CRS patients.
Who may be able to join
None listed.
Who cannot join
- no use of antibiotics in the past year
- no acute or chronic airway infections
- no cancer
- no autoimmune diseases
- pregnant women
- --> no exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Microbiota and the Potential of Probiotics for Chronic Rhinosinusitis
The aim of this study is to investigate whether the microbiota in the upper respiratory tract (URT) (nose, nasopharynx and sinuses) of chronic rhinosinusitis (CRS) patients is disturbed compared to healthy individuals. Therefore, bacterial DNA from swabs, aspirates and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics). A better understanding of the URT microbiome might help us to better understand the pathology of CRS and might help to develop new microbiota-based strategies for CRS.
- Conditions
- Microbiota Upper Respiratory Tract
- Being tested
- no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patientsOther
| Study group | Role | What they receive |
|---|---|---|
| Control group (healthy) | Participants who do not suffer from acute or chronic airway infections Receives: Other: no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patients | |
| CRS patients | Patients who suffer from chronic rhinosinusitis Receives: Other: no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in bacterial communities colonizing the upper respiratory tract between healthy individuals and CRS patients measured via Illumina MiSeq
After Illumina MiSeq sequencing, bio-informatic tools will be used to cluster bacteria into operational taxonomic units (OTUs). Based on these OTUs, we will compare the composition of the bacteria in the sampled niches and compare this composition between healthy individuals and chronic rhinosinusitis patients. We will specifically screen for OTUs that are over- or underrepresented in both populations. Furthermore, special attention will go to screen for the typical nasopharyngeal pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, ... and also to beneficial microbes such as lactic acid bacteria.
Measured: up to 4 years before all samples from both groups are collected and processed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startMay 2015
- Primary completion24 Aug 2018
- Study completion24 Aug 2018
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 Microbiota Upper Respiratory TractStudies 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
- Prospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité, UZA, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933983
- Sponsor's protocol ID
- B300201524257
- Acronym
- ProCure
- Status last verified
- Apr 2020
- First submitted
- 14 Jul 2016
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
De Boeck I, Wittouck S, Martens K, Claes J, Jorissen M, Steelant B, van den Broek MFL, Seys SF, Hellings PW, Vanderveken OM, Lebeer S. Anterior Nares Diversity and Pathobionts Represent Sinus Microbiome in Chronic Rhinosinusitis. mSphere. 2019 Nov 27;4(6):e00532-19. doi: 10.1128/mSphere.00532-19.
PubMed 31776238
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 Microbiota and the Potential of Probiotics for Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT02933983
- Acronym / sponsor ID
- ProCure / B300201524257
- Conditions
- Microbiota Upper Respiratory Tract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 24 Aug 2018 (actual)
- Study completion
- 24 Aug 2018 (actual)
- First posted
- 14 Oct 2016 (estimated)
- 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.
The aim of this study is to investigate whether the microbiota in the upper respiratory tract (URT) (nose, nasopharynx and sinuses) of chronic rhinosinusitis (CRS) patients is disturbed compared to healthy individuals. Therefore, bacterial DNA from swabs, aspirates and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Special attention will go to microbial species that are overrepresented in the healthy populations as potential health promoting microbes (i.e. probiotics). A better understanding of the URT microbiome might help us to better understand the pathology of CRS and might help to develop new microbiota-based strategies for CRS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (healthy) | – | Other: no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patientsParticipants who do not suffer from acute or chronic airway infections |
| CRS patients | – | Other: no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patientsPatients who suffer from chronic rhinosinusitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population involves both healthy individuals and CRS patients.
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- no use of antibiotics in the past year
- no acute or chronic airway infections
- no cancer
- no autoimmune diseases
- pregnant women
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 |
|---|---|---|
| no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patients | Other | CRS patients, Control group (healthy) |
Primary outcome
differences in bacterial communities colonizing the upper respiratory tract between healthy individuals and CRS patients measured via Illumina MiSeq
Time frame: up to 4 years before all samples from both groups are collected and processed
After Illumina MiSeq sequencing, bio-informatic tools will be used to cluster bacteria into operational taxonomic units (OTUs). Based on these OTUs, we will compare the composition of the bacteria in the sampled niches and compare this composition between healthy individuals and chronic rhinosinusitis patients. We will specifically screen for OTUs that are over- or underrepresented in both populations. Furthermore, special attention will go to screen for the typical nasopharyngeal pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, ... and also to beneficial microbes such as lactic acid bacteria.
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 31776238De Boeck I, Wittouck S, Martens K, Claes J, Jorissen M, Steelant B, van den Broek MFL, Seys SF, Hellings PW, Vanderveken OM, Lebeer S. Anterior Nares Diversity and Pathobionts Represent Sinus Microbiome in Chronic Rhinosinusitis. mSphere. 2019 Nov 27;4(6):e00532-19. doi: 10.1128/mSphere.00532-19.
- Individual participant dataSharing planned: No
Related trials for Microbiota Upper Respiratory Tract
Active, not recruiting
Microbiota and the Lung Cancer
Non Small Cell Lung Cancer
Recruiting
Clinical Trial to Evaluate the Efficacy of Lacticaseibacillus Rhamnosus CRL1505 in the Prevention of Upper Respiratory Tract Infections in Children
Upper Respiratory Tract Infection, Prevention
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 Microbiota Upper Respiratory Tract, 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 0 inclusion and 6 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?
differences in bacterial communities colonizing the upper respiratory tract between healthy individuals and CRS patients measured via Illumina MiSeq (time frame: up to 4 years before all samples from both groups are collected and processed). 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 NCT02933983, 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.