Protection from food induced anaphylaxis by reducing serum level of specific IgE

Phase 1

• Conditions: Food Allergy with Anaphylaxis; MedDRA version: 20.0Level: LLTClassification code 10014315Term: Egg allergySystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10016709Term: Fish allergySystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10040539Term: Shellfish allergySystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10001745Term: Allergy to cow's milkSystem Organ Class: 100000004870; MedDRA version: 20.1Level: LLTClassification code 10034202Term: Peanut allergySystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10027024Term: Meat allergySystem Organ Class: 100000004870; MedDRA version: 20.0Level: LLTClassification code 10011240Term: Cow's milk allergySystem Organ Class: 100000004870; MedDRA version: 20.1Level: LLTClassification code 10054957Term: Allergy to grainsSystem Organ Class: 100000004870; MedDRA version: 20.1Level: LLTClassification code 10054959Term: Allergy to nutsSystem Organ Class: 100000004870

• Registration Number: EUCTR2017-003627-30-DK
• Lead Sponsor: Odense Research Center for Anaphylaxis (ORCA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-01
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

•10 male or female subjects, age 18 - 70 years with verified allergy to a food allergen, where validated methods for determination of specific IgE to the food and to the major allergens (Component Resolved Diagnostics) are available. The foods include, but will not be confined to milk, egg, peanut, hazelnut, sesame, wheat, cod and shrimp. Patients with/without elevated levels of total IgE (> 1000 kIU/l) will be included. Minimum level of specific IgE to the major allergen component in the food in question will be 10 kIU/l. No control group will be included.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

•Ischemic heart disease or other significant co-morbidity (e.g. uncontrolled asthma) that might compromise the patient’s safety or study outcomes.
•Infection on the day of study
•Pregnancy or nursing
•Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused three days prior to the tests
•Ongoing treatment with ß-blockers that cannot be paused one day prior to the tests
•Ongoing treatment with oral glucocorticoids (>10 mg daily)
•Alcohol abuse, abuse of opioids or other drugs
•Occurrence of unexpected side effects
•Patients who are not supposed to be able to meet the requirements in the protocol
•Patients who are physically or mentally unable to consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified