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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT04090203
Eligibility Criteria:
Inclusion Criteria:
* Age 1-16 years
* History of immediate hypersensitivity reaction to peanut
* Evidence of IgE mediated peanut hypersensitivity within a 12 month period of study enrollment
* SPT with wheal/flare of at least 3 x 6 mm and/or Peanut specific IgE \>0.35 kU/L
Exclusion Criteria:
* History of life threatening peanut anaphylaxis
* Asthma requiring more than medium dose ICS
* Prior participation in oral immunotherapy, sublingual immunotherapy or epicutaneous immunotherapy
* Oat allergy
* Cardiovascular Disease
* Use of beta-blockers (oral), angiotensin converting enzyme inhibitors, angiotensin receptor blockers, or calcium channel blockers
* Use of steroid medications in the following manners:
* Daily oral steroid dosing for greater than 1 month during the past year
* Burst or steroid course in the past 3 month before inclusion
* Greater than 2 bursts oral steroid courses in the past year of at least 1 week duration
* Pregnancy or lactation
* Eosinophilic Gastrointestinal Disease
* History of food protein-induced enterocolitis
* History of developmental delay or speech delay that precludes age- appropriate communication, in the opinion of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
16 Years
Study:
NCT04090203
Study Brief:
Protocol Section:
NCT04090203