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 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT02192866
Eligibility Criteria:
Inclusion Criteria:
This protocol is to draw blood for a variety of related studies of food allergy. For this reason, we will list each group of subjects and the inclusion criteria for that group.
1. De-identified sera or plasma from patients who have undergone Oral ImmunoTherapy (OIT) for peanut allergy. These samples already exist.
* Inclusion criteria:
1. patients have been enrolled in a controlled trial of OIT for peanuts, and had at least one oral challenge.
2. Age 1-75.
2. De-identified samples from patients who are undergoing clinically indicated food challenges for peanut allergy.
* Inclusion criteria:
1. concern regarding possible allergy to peanuts,
2. age 1-75,
3. plan to undergo a clinically indicated challenge with peanuts.
3. Patients with peanut allergy.
* Inclusion criteria:
1. excellent history of a systemic reaction to peanuts,
2. age 6-75.
4. Patients with other food allergies (especially tree nuts).
* Inclusion criteria:
1. excellent history of a systemic reaction to tree nuts or other foods,
2. age 6-75.
5. Normal controls.
* Inclusion criteria:
1. no known food allergies,
2. recent ingestion of peanuts without difficulty, and
3. age 6-75.
Exclusion Criteria:
1. Any known significant medical or psychiatric diagnosis
2. Use of an investigational drug within 30 days
3. Use of omalizumab (anti-IgE; Xolair) within 6 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
75 Years
Study:
NCT02192866
Study Brief:
Protocol Section:
NCT02192866