- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239131
Prospective Study About Sensitization Pattern to Insects as Food Source in Patients With House Dust Mite Allergy (InFood)
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 Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Canton of Zurich
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Zurich, Canton of Zurich, Switzerland, 8091
- Allergy Unit,University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: All Patients
It is a single arm study.
Skin prick testing and laboratory Tests are carried out on all patients in the same way
|
a Skin prick test is planned in all patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone
Time Frame: 1 week
|
Sensitization (+/-)
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients
Time Frame: 1 week
|
Sensitization (+/-)
|
1 week
|
|
Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients
Time Frame: 1 week
|
Sensitization (+/-)
|
1 week
|
|
Sensitization pattern in insect sensitized patients in comparison between resident and immigrant populations in Switzerland
Time Frame: 1 week
|
Sensitization (+/-)
|
1 week
|
|
Sensitization pattern in seafood sensitized patients in comparison between resident and immigrant populations in Switzerland
Time Frame: 1 week
|
Sensitization (+/-)
|
1 week
|
|
Frequency of sensitization to the various insect allergens
Time Frame: 1 week
|
Sensitization (+/-)
|
1 week
|
|
Description of possible cross reactions between seafood and insect allergens
Time Frame: 1 week
|
Sensitization (+/-)
|
1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter Schmid, MD, Universitatsspital Zurich
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- InFood2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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