Microbiota Upper Respiratory Tract (ProCure)

April 7, 2020 updated by: Ethisch Comité, UZA, University Hospital, Antwerp

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • Antwerp University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population involves both healthy individuals and CRS patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group (healthy)
Participants who do not suffer from acute or chronic airway infections
Other: no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patients
CRS patients
Patients who suffer from chronic rhinosinusitis
Other: no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 4 years before all samples from both groups are collected and processed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

August 24, 2018

Study Completion (Actual)

August 24, 2018

Study Registration Dates

First Submitted

July 14, 2016

First Submitted That Met QC Criteria

October 13, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 7, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • B300201524257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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