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:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT02159833
Eligibility Criteria:
Inclusion Criteria:
* Aged 6 - 17 years old
* Physician-diagnosis of food allergy on the basis of:
* Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR
* History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR
* Evidence of \>95% likelihood of food allergy (on the basis of serum specific IgE or skin prick test (SPT) 8mm or above to the causative food allergen within past 12 months
* Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. Participants aged over 16 years will need to provide their owned informed consent.
Exclusion Criteria:
* Contraindicated as acutely unwell or current unstable asthma:
* Acute wheeze in last 72 hours requiring treatment
* Febrile ≥38.0oC in last 72 hours
* Recent admission to hospital in last 2 weeks for acute asthma
* Current medication
* Use of asthma reliever medication in last 72 hours
* Recent administration of a medication containing antihistamine within the last 4 days
* Current oral steroid for asthma exacerbation or course completed within last 2 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT02159833
Study Brief:
Protocol Section:
NCT02159833