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 @ 12:48 PM
Ignite Modification Date:
2025-12-24 @ 12:48 PM
NCT ID:
NCT02497261
Eligibility Criteria:
Challenge Inclusion Criteria:
CHILD study participants will be eligible for challenge if they
1. Have completed their 5-year-old CHILD Study visit
2. Are or have been sensitized to peanut i.e. have had a positive skin prick test (wheal diameter at least 2 mm greater than the negative control) and/or allergen-specific IgE level (\>0.35 kU/L) to peanut at their 1-, 3- and/or 5-year-old CHILD study visit
3. Are not eating peanut. Children who eat less than 8-10 g of peanut per month or who eat only foods that 'may contain' traces of peanut will still be eligible for inclusion.
Challenge Exclusion Criteria:
CHILD study participants will be ineligible for challenge if
1. They have never had a positive skin prick test or allergen-specific IgE level to peanut
2. They are eating 8-10 g of peanut at least once per month, despite having had a positive skin prick test or allergen-specific IgE level to peanut
3. Their family has declined to participate
4. They have a peanut skin prick test wheal size \>8mm and/or a peanut-specific IgE \>15 kU/L and a history suggestive of an IgE-mediated allergic reaction to peanut.
5. They have a history of anaphylaxis to peanut or a challenge-proven diagnosis of peanut allergy within the past 1-2 years.
6. They have uncontrolled asthma or any other contraindication to performing a DBPC food challenge on the day of challenge. These children may be rescheduled if their asthma control improves.
Blood Draw Inclusion Criteria:
CHILD study participants will be eligible for blood draw if they
1. Have completed their 5-year-old CHILD Study visit
2. Are or have been sensitized to peanut i.e. have had a positive skin prick test (wheal diameter at least 2 mm greater than the negative control) and/or allergen-specific IgE level (\>0.35 kU/L) to peanut at their 1-, 3- and/or 5-year-old CHILD study visit
Blood Draw Exclusion Criteria:
CHILD study participants will be ineligible for blood draw if
1. They have never had a positive skin prick test or allergen-specific IgE level to peanut
2. Their family has declined to participate
Immunological analyses of the blood samples are underway now that the 2 sites participating in this portion of the study (University of Manitoba and University of British Columbia) have completed their challenges. Challenges were halted in the spring.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
10 Years
Study:
NCT02497261
Study Brief:
Protocol Section:
NCT02497261