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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT04511494
Eligibility Criteria:
Inclusion Criteria:
* Children 1 - 3 years old at inclusion
* Positive baseline challenge at a maximum of the 250 mg peanut protein-dose with at least one objective symptom, or positive peanut challenge performed in the clinic in a similar way within 1 year from study start.
* IgE-ab to peanut and/or Ara h 2 ≥0.1 kUA/l, analyzed within 12 months from start of study
* Written consent for participation in the study from both Guardians
Exclusion Criteria:
* Other serious illness
* Previously life-threatening anaphylaxis (intensive care), regardless of the triggering agent
* A history of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, severe chronic gastroesophageal reflux disease (GERD), symptoms of dysphagia, unclear recurrent GI disorders
* Participation in another intervention study, if included in intervention Group
* Severe uncontrolled asthma
* Ongoing medication with biological drugs or oral steroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT04511494
Study Brief:
Protocol Section:
NCT04511494