Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT03964051
Eligibility Criteria:
Inclusion Criteria:
* Individuals aged 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.
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. Women of childbearing potential have to use safe contraception (intrauterine device or hormonal contraception (birth control pill, implant, transdermal patch, vaginal ring or depot injection)). Safe contraception has to be used during the whole trial period and half a year after the last dose of the trial medicine has been taken. It is accepted, if the female patient is permanently sterile or infertile, if her sole partner is permanently sterile or if they use both condom and diaphragm. The definition of sterile or infertile is surgically sterilized (vasectomy/bilateral salpingectomy, hysterectomy and/or bilateral ovariectomy) or post menopause defined as a non-menstrual period of at least 12 months before inclusion in the trial.
* Ongoing treatment with antihistamine or drugs with antihistaminic properties that cannot be paused three days prior to the tests
* Ongoing treatment with β-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
* Patients who have reduced liver function or kidney function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03964051
Study Brief:
Protocol Section:
NCT03964051