Clinical trial NCT04239131: Prospective Study About Sensitization Pattern to Insects as Food Source in Patients With House Dust Mite Allergy
Official title: A Prospective Study About the Sensitization Patterns to Insects as Food Source in Patients With House Dust Mite Allergy Based on Clinical History, Skin Prick Tests and in Vitro Tests
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypersensitivity, Food
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients allergic to seafood and/or sensitized to Tropomyosin of Skin Prick tests SPT or crustacean origin will may be also be sensitized to edible insects. Aim of the study is to evaluate whether patients allergic to seafood and/or sensitized to Tropomyosin of SPT or crustacean origin may be more often be sensitized to edible insects used as food source.

Detailed description: House dust mite allergy is a common problem in Europe. In addition to inhalant allergies sensitization to mites can be related to food allergy namely seafood. Insects are also widespread food sources in many regions of the world.

In this study skin testing and laboratory tests are planned in patients with known house dust mite allergy to evaluate a possible sensitization to insects. Patients must also complete a questionnaire. A drug therapy or other intervention is not planned.

Aim of the study is to evaluate whether patients allergic to seafood and/or sensitized to Tropomyosin of SPT or crustacean origin may be more often be sensitized to edible insects used as food source.

Eligibility criteria: Inclusion Criteria:

* Age: 18 \< x \< 70
* House dust mite sensitization with or without sensitization to seafood
* Subject is capable of giving informed consent
* Signed informed consent

Exclusion Criteria:

* Use of antihistamines, systemic corticosteroids during testing and within three days (antihistamines) or two weeks (corticosteroids) prior to testing
* Use of immunosuppressive agents
* History of cancer except for treated basal cell or spinal cell carcinoma of the skin
* Active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection, active or untreated latent tuberculosis.
* Female patients of childbearing potential who are pregnant or breast feeding or planning a pregnancy during the duration of the trial and/or not practicing acceptable birth control for the duration of the trial
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Previous enrollment into the current study,
* Enrollment of the investigator, his/her family members, employees and other dependent persons,

Primary outcomes:
measure: Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone
timeFrame: 1 week
Secondary outcomes:
measure: Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients
timeFrame: 1 week
measure: Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients
timeFrame: 1 week
measure: Sensitization pattern in insect sensitized patients in comparison between resident and immigrant populations in Switzerland
timeFrame: 1 week
measure: Sensitization pattern in seafood sensitized patients in comparison between resident and immigrant populations in Switzerland
timeFrame: 1 week
measure: Frequency of sensitization to the various insect allergens
timeFrame: 1 week
measure: Description of possible cross reactions between seafood and insect allergens
timeFrame: 1 week
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Allergy Unit,University Hospital
Study officials:
affiliation: Universitätsspital Zürich
name: Peter Schmid, MD
role: PRINCIPAL_INVESTIGATOR
References: