Microbiota Upper Respiratory Tract

Microbiota Upper Respiratory Tract Clinical Trial

— ProCure  

Official title:

Study of the Microbiota and the Potential of Probiotics for Chronic Rhinosinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933983
• Other study ID #: B300201524257
• Status: Completed
• Start date: May 2015
• Est. completion date: August 24, 2018

Study information

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

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: August 24, 2018
• Est. primary completion date: August 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Exclusion Criteria healthy population:

• no use of antibiotics in the past year

• no acute or chronic airway infections

• no cancer

• no autoimmune diseases

• pregnant women

Exclusion Criteria CRS population:

--> no exclusion criteria

Related Conditions & MeSH terms

• Microbiota Upper Respiratory Tract

Intervention

Other:
• no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patients

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 4 years before all samples from both groups are collected and processed