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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04239131
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Patients allergic to seafood and/or sensitized to Tropomyosin of 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.

Condition or disease Intervention/treatment Phase
Hypersensitivity, Food Other: Skin prick test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
All Patients
It is a single arm study. Skin prick testing and laboratory Tests are carried out on all patients in the same way
Other: Skin prick test
a Skin prick test is planned in all patients




Primary Outcome Measures :
  1. Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone [ Time Frame: 1 week ]
    Sensitization (+/-)


Secondary Outcome Measures :
  1. Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients [ Time Frame: 1 week ]
    Sensitization (+/-)

  2. Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients [ Time Frame: 1 week ]
    Sensitization (+/-)

  3. Sensitization pattern in insect sensitized patients in comparison between resident and immigrant populations in Switzerland [ Time Frame: 1 week ]
    Sensitization (+/-)

  4. Sensitization pattern in seafood sensitized patients in comparison between resident and immigrant populations in Switzerland [ Time Frame: 1 week ]
    Sensitization (+/-)

  5. Frequency of sensitization to the various insect allergens [ Time Frame: 1 week ]
    Sensitization (+/-)

  6. Description of possible cross reactions between seafood and insect allergens [ Time Frame: 1 week ]
    Sensitization (+/-)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 immunsuppressive 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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239131


Contacts
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Contact: Peter Schmid, MD +41 44 255 30 79 peter.schmid@usz.ch

Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Peter Schmid, MD Universitätsspital Zürich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04239131    
Other Study ID Numbers: InFood2020
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate