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 @ 10:55 PM
Ignite Modification Date:
2025-12-24 @ 10:55 PM
NCT ID:
NCT00465569
Eligibility Criteria:
Inclusion Criteria:
* Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable
* Age 6 to 21 years
* Must have history of symptomatic reactivity to cow's milk (eczema, urticaria, upper/lower resp., GI, other associated rash, oral symptoms)
* History of positive skin prick test (wheal \>/= histamine control) or milk-Immunoglobulin E (IgE)\>0.35 kilounits per liter (kU/L)
* Positive DBPCFC
* All females of child bearing age must be using appropriate birth control
Exclusion Criteria:
* History of anaphylaxis requiring hospitalization
* History of intubation related to asthma
* Has the ability to tolerate \>2.4gram of milk protein at initial DBPCFC
* Has a history of allergy to any component of vehicle
* Pregnancy (need negative test)
* Viral upper respiratory infection (URI) or gastroenteritis within 7days of OFC (OFC needs to be rescheduled)
* Has pulmonary function tests \<80% of predicted (FEV1) or clinical history consistent with moderate persistent asthma
* Currently taking greater than medium dose inhaled corticosteroid (\>400mcg/day fluticasone or fluticasone equivalent if \</=12yo or \>600mcg/day if \>12 years old)
* Antihistamine within 1 week prior to skin testing or food challenges (Skin testing and/or food challenge needs to be rescheduled)
* Systemic corticosteroid within 4 weeks prior to baseline visit
* Receiving omalizumab, beta-blocker, Angiotensin-converting enzyme (ACE) inhibitor or tricyclic antidepressant therapy
* Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
* Participation in any interventional study for treatment of a food allergy in the past 12 months
* Severe reaction at initial DBPCFC, defined as:
i. Life-threatening anaphylaxis ii. Requires overnight hospitalization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
21 Years
Study:
NCT00465569
Study Brief:
Protocol Section:
NCT00465569