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 @ 10:40 PM
Ignite Modification Date:
2025-12-24 @ 10:40 PM
NCT ID:
NCT00815035
Eligibility Criteria:
Inclusion Criteria:
* Age 1- 6 years all of either sex, any race, any ethnicity at the time of the initial visit
* The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal \>3.0 mm) and a positive in vitro IgE \[CAP-FEIA\] \> 7 kUA/L
* A history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts
* Provide signed informed consent
Exclusion Criteria:
* History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or oxygen saturation \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
* Currently participating in a study using an investigational new drug
* Participation in any interventional study for the treatment of food allergy in the past 12 months
* Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat
* Poor control or persistent activation of atopic dermatitis
* Moderate to severe persistent asthma
* Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines
* Inability to discontinue antihistamines for skin testing and oral food challenges (OFCs)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
6 Years
Study:
NCT00815035
Study Brief:
Protocol Section:
NCT00815035