Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05061329

The Importance of the Nasal Microbiome in Transmission and Disease

Led by University of Aarhus · Updated on 2023-12-07

619

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the nasal microbiome and its role in various conditions including normal health, olfactory dysfunction, COVID-19, long COVID-19 with lasting olfactory issues, and chronic rhinosinusitis (CRS) with and without nasal polyps. The study aims to understand how the nasal microbiome and immune factors interact and differ among these groups, with a focus on how treatments like intranasal glucocorticoids and biological therapies might influence these factors. Participants include six groups: healthy individuals without nasal or airway diseases, non-COVID patients with olfactory dysfunction, COVID-19 positive patients in the acute phase, long COVID-19 patients with persistent olfactory dysfunction, patients with CRS starting intranasal steroid treatment, and those beginning biological therapy. Samples collected include nasal and oral swabs for microbiome analysis using advanced sequencing methods, nasal biopsies for histological and spatial transcriptomic studies, and nasal secretions for cytokine profiling. Follow-up occurs at six months for microbiome differences and after 24 weeks for patients starting steroid treatment. Participants undergo medical history reviews, ear, nose, and throat examinations including endoscopy, smell and taste testing, and questionnaires assessing nasal symptoms and mental health. Researchers analyze microbial diversity and immune markers from collected samples to measure differences in microbiome composition and immune responses. Safety is ensured through exclusion of patients with bleeding risks for biopsies, and all procedures comply with ethical and data protection standards. The study is led by the University of Aarhus and involves collaboration with specialized institutes.

CONDITIONS

Brief Title

The Nasal Microbiome and Its Importance in Disease

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
Not Eligible

You will not qualify if you...

  • Does not wish to participate in study
  • Active anticoagulation treatment for biopsy groups
  • Diseases affecting blood clotting
  • Antibiotic use within the last three months
  • Use of immunomodulating drugs within the last three months
  • Autoimmune disease or immunodeficiency
  • Bleeding risk excludes participation in biopsy procedures
  • Exclusion for any contraindications to nasal biopsy procedures or treatments as specified in study protocol
  • Patients unable or unwilling to provide informed consent or samples as required by the study protocol
  • Any other medical condition or treatment that contraindicates participation as determined by the investigators

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline and up to 6 months

Participants undergo clinical examinations and microbiome sampling to assess nasal microbiome and immune factors.

1 baseline visit and follow-up assessments over 6 months

Long-term Monitoring

Duration - Up to 6 months

Participants are observed over time to study seasonal fluctuations and changes in nasal microbiome and immune factors.

Follow-up visits depending on cohort assignment

Trial Site Locations

Total: 1 location

1

Ear, Nose and Throat Department, HEV

Holstebro, Central Jutland, Denmark, 7500

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Research Team

L

Laura Marie Aalkjær Danielsen

T

Therese Ovesen, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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