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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45249

Enrollment

Registered

2017-11-22

Start date

2017-08-29

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhinitis house dust mite allergy

Interventions

Skin tests, nasal biopsies, nasal provocation, blood sampling

adult

house dust mite allergy

immune modulation

nasal challenge

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Nasal response to house dust mites after challenge	—

Secondary

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

Measure

Time frame

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

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)