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 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 12:24 AM
NCT ID:
NCT00597558
Eligibility Criteria:
Inclusion Criteria:
* Between 1 to 16 years of age
* Diagnosed egg allergy by CAP FEIA to egg of 5 kU/l or greater (2 kU/l or greater if 2 years old or less) or have had a positive allergic reaction to egg within 6 months.
* Having eaten egg in his/her diet prior to diagnosis
* A family that will be able to be compliant with all study visits
* All females of child bearing age must be using appropriate birth control
Exclusion Criteria:
* History of anaphylaxis to egg
* Medical history that would prevent a DBPCFC (double-blind placebo-controlled food challenge) to egg. The medical history that would prevent the DBPCFC to egg would be a prior history of an open egg challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an FEV1 \< 80% of predicted, or FEV1/FVC \<75%, with or without controller medications
* Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
* Diagnosed corn allergy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
16 Years
Study:
NCT00597558
Study Brief:
Protocol Section:
NCT00597558