Study on the investigation of sensitization patterns to insects as food using clinical history, skin tests, and laboratory examinations in patients with house dust mite allergy

Switzerland (ICTRP)

ICTRP Trial ID
NCT04239131 (ICTRP)

Official title (approved by ethics committee)
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. InFood Study (BASEC)

Academic 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 (ICTRP)

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

Disease under investigation
Hypersensitivity, Food (ICTRP)

Intervention under investigation
Other: Skin prick test (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)

Inclusion/Exclusion 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, (ICTRP)

not available

Primary and secondary end points
Presence/absence of insect sensitization among seafood/Tropomyosin-sensitized patients versus patients with house dust mite sensitization alone (ICTRP)

Sensitization pattern in insect sensitized patients in comparison between seafood-sensitized versus non-seafood-sensitized patients;Sensitization pattern in seafood sensitizes patients in comparison between insect-sensitized versus non-insect-sensitized patients;Sensitization pattern in insect sensitized patients in comparison between resident and immigrant populations in Switzerland;Sensitization pattern in seafood sensitized patients in comparison between resident and immigrant populations in Switzerland;Frequency of sensitization to the various insect allergens;Description of possible cross reactions between seafood and insect allergens (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
Peter Schmid, MD, Universitätsspital Zürich (ICTRP)

Secondary trial IDs
InFood2020 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/study/NCT04239131 (ICTRP)