Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis

Chronic Sinusitis Clinical Trial

— METEL-RC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04418622
• Other study ID #: METEL-RC (29BRC19.0162)
• Status: Completed
• Start date: October 21, 2020
• Est. completion date: November 15, 2021

Study information

• Verified date: November 2021
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	description of biodiversity of the microbiota	Shannon index	six month
Primary	richness of samples	number of OTU (operational taxonomic unit)	six month
Secondary	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
Secondary	rhinosinusal inflammation	lund kennedy score. Minimum 0. maximum 10. the higher the score the greater the signs of chronic rhinosinusitis.	six month