Prospective Study About Sensitization Pattern to Insects as Food Source in Patients With House Dust Mite Allergy (InFood)
Primary Purpose
Hypersensitivity, Food
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Skin prick test
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypersensitivity, Food
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,
Sites / Locations
- Allergy Unit,University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All Patients
Arm Description
It is a single arm study. Skin prick testing and laboratory Tests are carried out on all patients in the same way
Outcomes
Primary Outcome Measures
Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone
Sensitization (+/-)
Secondary Outcome Measures
Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients
Sensitization (+/-)
Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients
Sensitization (+/-)
Sensitization pattern in insect sensitized patients in comparison between resident and immigrant populations in Switzerland
Sensitization (+/-)
Sensitization pattern in seafood sensitized patients in comparison between resident and immigrant populations in Switzerland
Sensitization (+/-)
Frequency of sensitization to the various insect allergens
Sensitization (+/-)
Description of possible cross reactions between seafood and insect allergens
Sensitization (+/-)
Full Information
NCT ID
NCT04239131
First Posted
January 6, 2020
Last Updated
February 17, 2022
Sponsor
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT04239131
Brief Title
Prospective Study About Sensitization Pattern to Insects as Food Source in Patients With House Dust Mite Allergy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity, Food
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All Patients
Arm Type
Other
Arm Description
It is a single arm study. Skin prick testing and laboratory Tests are carried out on all patients in the same way
Intervention Type
Other
Intervention Name(s)
Skin prick test
Intervention Description
a Skin prick test is planned in all patients
Primary Outcome Measure Information:
Title
Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone
Description
Sensitization (+/-)
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients
Description
Sensitization (+/-)
Time Frame
1 week
Title
Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients
Description
Sensitization (+/-)
Time Frame
1 week
Title
Sensitization pattern in insect sensitized patients in comparison between resident and immigrant populations in Switzerland
Description
Sensitization (+/-)
Time Frame
1 week
Title
Sensitization pattern in seafood sensitized patients in comparison between resident and immigrant populations in Switzerland
Description
Sensitization (+/-)
Time Frame
1 week
Title
Frequency of sensitization to the various insect allergens
Description
Sensitization (+/-)
Time Frame
1 week
Title
Description of possible cross reactions between seafood and insect allergens
Description
Sensitization (+/-)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Schmid, MD
Phone
+41 44 255 30 79
Email
peter.schmid@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Schmid, MD
Organizational Affiliation
Universitätsspital Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Unit,University Hospital
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PETER SCHMID
Phone
+41442553079
Email
peter.schmid@usz.ch
12. IPD Sharing Statement
Plan to Share IPD
No
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Prospective Study About Sensitization Pattern to Insects as Food Source in Patients With House Dust Mite Allergy
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