NCT05061329 The Nasal Microbiome and Its Importance in Disease
| NCT ID | NCT05061329 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Chronic Rhinosinusitis (Diagnosis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 619 participants |
| Start Date | 2020-12-21 |
| Primary Completion | 2026-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 619 participants in total. It began in 2020-12-21 with a primary completion date of 2026-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: Exclusion Criteria: * Does not wish to participate in study
Contact & Investigator
Laura Marie Aalkjær Danielsen
PRINCIPAL INVESTIGATOR
student
Frequently Asked Questions
Who can join the NCT05061329 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Rhinosinusitis (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05061329 currently recruiting?
Yes, NCT05061329 is actively recruiting participants. Contact the research team at lauraaalkjaer@hotmail.com for enrollment information.
Where is the NCT05061329 trial being conducted?
This trial is being conducted at Holstebro, Denmark.
Who is sponsoring the NCT05061329 clinical trial?
NCT05061329 is sponsored by University of Aarhus. The principal investigator is Laura Marie Aalkjær Danielsen at student. The trial plans to enroll 619 participants.