Completed

NCT Number: NCT02933983

Microbiota Upper Respiratory Tract

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.

Completed

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Key information

Conditions

Microbiota Upper Respiratory Tract

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

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

Acronym: ProCure

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Oct 14, 2016
Registry last updated: Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.