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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT00578656
Eligibility Criteria:
Inclusion Criteria:
* Positive prick skin test to milk and/or detectable serum milk-IgE
* History of allergic reaction to milk within past 6 months
* Serum milk-IgE of high predictive value (\>15 in children older than 1 year, \>5 in children younger than 1 year)
* Asymptomatic or stabilized atopic disease (asthma, allergic rhinitis, atopic dermatitis) for a minimum of 7 days prior to OFC
Exclusion Criteria:
* Serum level of cow's milk-specific IgE antibody greater than 35 kIU/L
* History of anaphylactic reaction to cow's milk within the past 12 months
* Unstable asthma
* Allergic eosinophilic gastroenteritis caused by milk
* Use of short-acting antihistamines more than one time within 3 days of OFC
* Use of medium-acting antihistamines more than one time within 7 days of OFC
* Maintenance therapy or use of beta-blockers and ACE inhibitors within 12 to 24 hours of OFC
* Participation in study baked egg study GCO#03-0609 within 6 months of enrollment
* Pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
25 Years
Study:
NCT00578656
Study Brief:
Protocol Section:
NCT00578656