The study is focused at developing new ways of treating allergic disorders. With this study we aim at evaluating the effects of helicobacter and Schistosoma molecules on nasal tissue stimulated by allergen exposure. The study will clarify mechanisms…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Nasal response to house dust mites after challenge
Secondary outcome
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.
Background summary
In recent decades the prevalence of allergic diseases such as rhinitis and
asthma have increased substantially. Treatment is restricted to allergen
avoidance, pharmacotherapy and immunotherapy. The latter therapy is capable to
modify the allergic reaction, to decrease symptoms, to influence the natural
course of disease and to prevent the development of asthma. This therapeutic
modality is however time consuming, burdensome and not without side effects.
Thus, there is a need for new and innovative ways of treatment. Certain
gastro-intestinal bacteria like Helicobacter pylori and helminth parasites were
shown to protect against allergic airway disease and asthma
Study objective
The study is focused at developing new ways of treating allergic disorders.
With this study we aim at evaluating the effects of helicobacter and
Schistosoma molecules on nasal tissue stimulated by allergen exposure. The
study will clarify mechanisms and identify potential molecules eligible for
treatment of allergic patients in the future.
Study design
Nasal biopsies will be taken from patients with allergic rhinitis based on a
HDM allergy and healthy subjects a week before and a day after a series of 3
nasal provocation tests on consecutive days. At baseline subjects will be
screened with a questionnaire and skin test. Blood samples will be taken. We
aim to recruit 30 patients and 30 healthy subjects. The duration of the study
amounts two weeks for individual participants.
Intervention
Skin tests, nasal biopsies, nasal provocation, blood sampling
Study burden and risks
The study requires 6 visits, limited burden from skin tests and blood sampling.
Slight discomfort from nasal challenge (sneezing, watery discharge, blockage)
and biopsy with a sporadic change of bleeding after the biopsy.
Burg.'s Jacobplein 51
Rotterdam 3015 CA
NL
Burg.'s Jacobplein 51
Rotterdam 3015 CA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58623.078.16 |