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

Hypersensitivity, Food Clinical Trial

— InFood  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04239131
• Other study ID #: InFood2020
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: December 2023

Study information

• Verified date: February 2022
• Source: University of Zurich
• Contact: Peter Schmid, MD
• Phone: +41 44 255 30 79
• Email: peter.schmid[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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,

Related Conditions & MeSH terms

• Food Hypersensitivity
• Hypersensitivity
• Hypersensitivity, Food

Intervention

Other:
• Skin prick test
a Skin prick test is planned in all patients

Locations

Country	Name	City	State
Switzerland	Allergy Unit,University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone	Sensitization (+/-)	1 week
Secondary	Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients	Sensitization (+/-)	1 week
Secondary	Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients	Sensitization (+/-)	1 week
Secondary	Sensitization pattern in insect sensitized patients in comparison between resident and immigrant populations in Switzerland	Sensitization (+/-)	1 week
Secondary	Sensitization pattern in seafood sensitized patients in comparison between resident and immigrant populations in Switzerland	Sensitization (+/-)	1 week
Secondary	Frequency of sensitization to the various insect allergens	Sensitization (+/-)	1 week
Secondary	Description of possible cross reactions between seafood and insect allergens	Sensitization (+/-)	1 week