Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis (METEL-RC)

Evolution of the Endonasal Microbiota After Endoscopic and Local Treatment or Local Treatment Alone in Patients With Chronic Rhinosinusitis

Chronic rhinosinusitis (CRS) is defined according to the French society of otorhinolaryngology as chronic non-mechanical damage to the nasal structures, excluding infectious damage to the sinus structures. The duration of the chronic impairment must be at least 12 consecutive weeks. It causes many symptoms such as rhinorrhea, nasal blockage and anosmia. It is a poorly understood pathology that affects a large part of the population. Its prevalence has increased significantly over the past 30 years. It affects about 11% of the population in Europe. It has become one of ten high-cost medical conditions for employers. Initially, it was accepted that CRS was due to chronic nasal infection. It is very debilitating for patients leading to a major consultation with practitioners (general practitioners and ENT specialists). Many treatments are used such as nose washes, nasal or oral corticosteroids, antibiotic therapy or even surgical management is possible. Thèses treatments allow an improvement in the symptomatology but no treatment allows a stable result over time, making long-term treatments essential.

Today, it is recognized that CRS has a multifactorial etiology including inflammatory processes, hyperresponsiveness of the nasal mucosa and abnormalities in immune phenomena. The endonasal microbiota plays a role in these processes. Germs like Staphylococcus aureus and Pseudomonas aeruginosa were identified as pathogens in CRS in the first studies with bacterial cultures. Thanks to the 16S ribosomal RNA sequencing technique, recent studies have demonstrated a modification in the diversity and abundance of the microbiota in patients with CRS compared to healthy subjects, notably with a modification of the germs of the firmicutes group. .

Few studies have studied the modification of the microbiota with the treatment of CRS today. However, local treatments based on nosewashing with physiological saline associated with local corticosteroids and endoscopic treatments lead to an improvement in the symptomatology for patients suffering from CRS. This study will describe the modification of endonasal microbiota in différent conditions, such medical and surgical treatments, that usually improve patients symptomatology.

Study Overview

• Status: Completed
• Conditions: Chronic Sinusitis

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients without chronic rhinosinusitis who undergo a nasal surgery and patients with chronic rhinosinusitis who undergo a medical or surgical treatment

Description

Inclusion Criteria:

• patients without chronic rhinosinusitis who undergo a nasal surgery
• patients with chronic rhinosinusitis who undergo a medical or surgical treatment

Exclusion Criteria:

• minor patients
• pregnant or lactating women
• patients undergoing antibiotic therapy in the month preceding the start of the study
• patients with immunosuppression
• ENT cancer or other cancer in progress
• primary ciliary dyskinesia or cystic fibrosis
• Systemic vasculitis (Wegener, Gougerot-Sjögren ...)
• Refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
description of biodiversity of the microbiota	Shannon index	six month
richness of samples	number of OTU (operational taxonomic unit)	six month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient quality of life	specific questionnaire Sino-nasal Outcome Test (SNOT-22). minimum 0 maximum 110. The higher the score the greater the impact of the symptoms on quality of life.	six month
rhinosinusal inflammation	lund kennedy score. Minimum 0. maximum 10. the higher the score the greater the signs of chronic rhinosinusitis.	six month

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: METEL-RC (29BRC19.0162)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending five years following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the international committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol