PROtective Microbial SubstancEs: a nasal challenge and biopsy study in HDM allergic patients and healthy subjects.

Completed

Conditions: allergic rhinitis
house dust mite allergy
10001708

Registration Number: NL-OMON45249

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Patients:
.18-50 years
.Clinically relevant moderate to severe allergic rhinitis as assessed by the ARIA criteria due to a sensitization for house dust mite
-Positive nasal challenge test to HDM
-Signed informed consent;Healthy subjects:
-18-50 years
-Absence of allergic rhinitis or other nasal disorders
-Negative skin prick test to HDM, birch pollen, grass pollen, cat and dog or other animals the patient is in daily contact with.
-Signed informed consent

Exclusion Criteria

Patients:
-Inability to stop nasal corticosteroids 3 weeks and antihistamines 3 days before the provocation
- Allergy to animals the patient is in daily contact with pets
-Immunological diseases, cardiovascular diseases or malignity
-Previous or current immunotherapy
-Nasal polyps
-Unable to speak and understand the Dutch language properly.
-Not willing to comply with the study procedures
-Pregnancy;Healthy subjects
* Anatomical or other disorders of the nose
* Language barrier
* Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Nasal response to house dust mites after challenge</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Several laboratory outcomes: Cellular composition within the nasal cavity<br /><br>tissue ; Epigenetic profile of isolated antigen-presenting cell populations;<br /><br>Cytokine production and activation status of dendritic cells and T cells<br /><br>stimulated with helicobactor and Schistosoma molecules; Microbiome composition<br /><br>within the nasal cavity as determined by 16s rRNA gene-based sequencing; RNA<br /><br>sequencing analysis of isolated antigen-presenting cells; Tryptase and cytokine<br /><br>levels within the fluid of the nasal cavity as a measure of induced<br /><br>inflammation. Analysis to IL C2 cells.</p><br>