Prospective Study About Sensitization Pattern to Insects as Food Source in Patients With House Dust Mite Allergy

Not Applicable

• Conditions: Hypersensitivity, Food
• Interventions: Other: Skin prick test

• Registration Number: NCT04239131
• Lead Sponsor: University of Zurich

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.

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-23
• Study Start: 2021-03-15
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-04
• Primary Completion: 2023-07
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Patients	Skin prick test	It is a single arm study. Skin prick testing and laboratory Tests are carried out on all patients in the same way

Primary Outcome Measures

Name	Time	Method
Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone	1 week	Sensitization (+/-)

Secondary Outcome Measures

Name	Time	Method
Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients	1 week	Sensitization (+/-)
Sensitization pattern in insect sensitized patients in comparison between resident and immigrant populations in Switzerland	1 week	Sensitization (+/-)
Sensitization pattern in seafood sensitized patients in comparison between resident and immigrant populations in Switzerland	1 week	Sensitization (+/-)
Description of possible cross reactions between seafood and insect allergens	1 week	Sensitization (+/-)
Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients	1 week	Sensitization (+/-)
Frequency of sensitization to the various insect allergens	1 week	Sensitization (+/-)

Trial Locations

Locations (1)

Allergy Unit,University Hospital; 🇨🇭 Zurich, Switzerland