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
Zusammenfassung der Studie
This study aims to investigate whether people with a house dust mite allergy may have a greater risk of allergic reactions to insects as food, especially if they are already allergic to seafood. Additionally, we want to examine whether this risk may also be influenced by where one grew up or currently lives. Furthermore, we will investigate what sensitizations to insects are found in employees who regularly come into professional contact with edible insects. In a subgroup of participants, we will also investigate whether they may react allergically to chicken meat.
(BASEC)
Untersuchte Intervention
Skin tests (prick test) and blood tests
(BASEC)
Untersuchte Krankheit(en)
Insect allergy House dust mite allergy Shellfish allergy
(BASEC)
• Age between 18 and 70 years • House dust mite allergy with or without shellfish allergy or regular professional contact with edible insects or none of these criteria (control group) (BASEC)
Ausschlusskriterien
• Use of antihistamines, systemic glucocorticoids during testing and for three days (antihistamines) or two weeks (glucocorticoids) prior • Treatment with immunosuppressive medications • Active or recurrent bacterial, viral, or fungal infections at the time of inclusion in the study, including HIV, hepatitis B or C, and tuberculosis (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Prof. Dr. med. Peter Schmid-Grendelmeier
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Peter Schmid-Grendelmeier
+41 44 244 3079
peter.schmid@clutterusz.chAllergiestation, Dermatologische Klinik, Universitätsspital Zürich, Rämistrasse 100, 8091 Zürich
(BASEC)
Allgemeine Auskünfte
Universitätsspital Zürich
(ICTRP)
Allgemeine Auskünfte
Universittsspital Zrich
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
16.04.2020
(BASEC)
ICTRP Studien-ID
NCT04239131 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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)
Öffentlicher Titel
Prospective Study About Sensitization Pattern to Insects as Food Source in Patients With House Dust Mite Allergy (ICTRP)
Untersuchte Krankheit(en)
Hypersensitivity, Food (ICTRP)
Untersuchte Intervention
Other: Skin prick test (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Peter Schmid, MD, Universitätsspital Zürich (ICTRP)
Sekundäre IDs
InFood2020 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT04239131 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar