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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT04604912
Eligibility Criteria:
For the allergic cohort :
Inclusion criteria:
* 2-70 years
* male or female
* Allergic to peanut (assessed by anamnesis, skinreactivity testing, sera testing for specific IgE)
* Sign an Informed Consent
* Diagnostic food challenge scheduled
Exclusion criteria:
* Significant co-morbidity
* Medical treatment by nonsteroidal anti-inflammatory drugs oraspirin, chronic treatment with beta-blockers,angiotensin-converting enzyme inhibitors, use ofantihistamines within 5 days of oral food challenge and oral corticosteroids within 14 days prior to the challenge
* Medical unfit for challenge (e.g : fever,unwell with intercurrent illness)
* Pregant women
* Unbalanced asthma
* Severe food-induced anaphylaxis
For the control cohort :
Inclusion criteria:
* Adults
* male or female
* Sign an Informed Consent
* Tolerance to peanuts and fish (IgE-titer \< 0.10 kUA/L)
Exclusion criteria
* Pregnancy
* Medical unfit for challenge (e.g : fever, unwell with intercurrent illness),
* Unbalanced asthma
* Treatment by nonsteroidal anti-inflammatory drugs or aspirin
* Chronic treatment with beta-blockers, angiotensin-converting enzyme inhibitors
* Use of antihistamines within 5 days of oral food challenge
* Oral corticosteroids within 14 days prior to the challenge
* Risk of severe food-induced anaphylaxis in highly sensitized peanut-allergic patients
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
70 Years
Study:
NCT04604912
Study Brief:
Protocol Section:
NCT04604912