Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis

NCT04418622 | Completed

• 1 other identifier: METEL-RC (29BRC19.0162)
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Sinusitis

Outcome Measures

Primary Outcomes (2)

• description of biodiversity of the microbiota

  Shannon index

  six month

• richness of samples

  number of OTU (operational taxonomic unit)

  six month

Secondary Outcomes (2)

• patient quality of life

  six month

• rhinosinusal inflammation

  six month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 5, 2020
• Study Start: October 21, 2020
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after the publication of result and ending five years following the last visit of the last patient
• 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.

Locations

FR (1)