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

Odense Research Center for Anaphylaxis (ORCA)0 个研究点目标入组 10 人开始时间: 2018年3月1日最近更新: 2021年3月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

Odense Research Center for Anaphylaxis (ORCA)