The Nasal Microbiome and Its Importance in Disease

NCT05061329 | Recruiting DMC

• 1 other identifier: NasalMicrobiomeTO,LD,KF
• Study Type: observational
• Target: 619
• Locations: 1 country
• Sites: 1

Brief Summary

Methods: all studies are case control studies on six different groups: normal individuals, non-COVID-19 patients with olfactory dysfunction, COVID-19 positive patients, previous COVID-19 positive patients with prolonged olfactory dysfunction, patients with chronic rhinosinusitis with and without nasal polyps, and patients with CRS initiating intranasal glucocorticoids.. The patients will be included from the ear-, nose, and throat department and the University Clinic for Flavour, Balance, and Sleep Regional Hospital Gødstrup, as well as Flavour Institute, Department of Clinical Medicine, Aarhus University (AU), and the long COVID-19 clinics in Aarhus and Gødstrup. Microbiome samples will be swabs from the nasal cavity and oral pharynx will be collected and analysed using next-generation sequencing targeting 16S and 18S ribosomal RNA at the Department of Bacteria, Parasite \& Fungi at Staten Serum Institute (SSI), Copenhagen, Denmark. Characterization of the microbiome is performed by 16S/18S amplicon-based metagenomics, and data are analyzed by various bio-informatic tools for determination/visualization of alpha/beta diversity as well as principal coordinates analysis (PCoA). Immunological factors will be collected by means of six swabs: in the nasal cavity and used for either flowcytometry or enzyme-linked immunosorbent assay (ELISA). For comparison, truecut biopsies of the nasal mucosa are collected from a subgroup of patients undergoing surgery in general anaesthesia. Due to the novelty of the current study, little relevant information from previous literature can be used for power calculation. However, with an alpha of 5% and a power of 80%, the population size for each group should be 42 participants, assuming the occurrence of bacteria differs with 30% between populations. Taking 20% drop out into account, the investigators aim to include 60 patients in each group. Perspectives: The perspectives of this study is to begin bridging the gap between gut and upper airway microbiome and immunology research. Looking at the explosion of interest in the gut, and in personalized medicine in general, the investigators likewise foresee a huge potential for both general and individual prevention and treatments starting with a deeper understanding of the nasal microbiome and immunology. Examples beyond the scope of this study could be microbiome transplants for chronic sufferers of diseases such as chronic rhinosinusitis, allergies or asthma, or in selecting which patients could reap the benefits of the expensive biological treatments emerging on the market.

Conditions

Chronic Rhinosinusitis (Diagnosis); COVID-19; Anosmia

Outcome Measures

Primary Outcomes (1)

• Microbiome difference

  Difference in microbiome between the defined groups

  6 months

Secondary Outcomes (2)

• Effect of nasal glucocorticoids on nasal microbiome

  6 months

• Correlation between TDI score and nasal microbiome

  6 months

Study Arms (6)

60 Normal individuals

Normal sense of smell and absence of sino-nasal disease, upper airway allergies, and no intranasal medication

60 Non-COVID-19 positive patients

with olfactory dysfunction

15 COVID-19 positive patients

In the acute phase

60 long COVID-19 patients

with olfactory dysfunction persisting for more than 12 weeks

60 patients with chronic rhinosinuitis

initiating intranasal glucocorticoids

15 patients with chronic rhinosinuitis

initiating biological treatment with either dupilumab or mepolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Normal individuals: no sino-nasal disease - no upper airway allergies - no intra nasal medication - normal sense of smell 2. Patients with smell loss 3. COVID-19 positive patients 4. Previous COVID-19 positive patients with prolonged olfactory dysfunction 5. Patients with chronic rhinosinusitis with and without nasal polyps Recruitment: population 1, 5, and 6 are recruited among patients undergoing surgery at the ENT department, Regional Hospital West Jutland, Denmark. Populations 2 and 4 are enrolled from the Flavour Clinic, ENT department, Regional Hospital Denmark. Population 3 is recruited at the COVID-19 clinics in Aarhus and Herning. Population 1 will be supplied with staff members and university students.

You may not qualify if:

• Does not wish to participate in study

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Ear, Nose and Throat Department, HEV

Holstebro, Central Jutland, 7500, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiome swabs

MeSH Terms

Conditions

Disease; COVID-19; Anosmia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Laura Marie Aalkjær Danielsen

  student

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Marie Aalkjær Danielsen

CONTACT

+4542714748; lauraaalkjaer@hotmail.com

Therese Ovesen, MD

CONTACT

53800777; theroves@rm.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 29, 2021
• Study Start: December 21, 2020
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

DK (1)