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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT01950559
Eligibility Criteria:
Inclusion Criteria:
* Age 6 months to 40 years of any sex and any race
* A convincing history of allergic reaction to soybean and a positive ImmunoCAP (\>0.35 kU/L) and/or a positive skin prick test to soy. Subjects should have ImmunoCAP repeated (if not done within the last 6 months) at National Jewish Health.
* One of the following:
A) Recent (within one year) failed open OFC B) Positive DBPCFC to soy at NJH; or C) Recent (within one year) exposure to soybean resulting in immediate IgE-mediated allergic symptoms (within 2 hours of ingestion; symptoms such as urticaria, angioedema, congestion, rhinorrhea, wheezing).
* Written informed consent from parent/guardian and assent (when age appropriate).
* Willingness to submit specimen for laboratory serum IgE testing
* Willingness to submit lab specimen for ELISA testing
Exclusion Criteria:
* Inability to discontinue antihistamines for skin prick testing and OFCs
* Current allergy to placebo ingredient (oat flour) OR reaction to any dose of placebo at the qualifying OFC
* FEV1 value \<80% predicted or any clinical features of moderate or severe persistent asthma, as defined by the 2007 NHLBI guidelines table for classifying asthma severity (Step 3 or above), and greater than high daily doses of inhaled corticosteroids, as defined by the 2007 NHLBI guidelines inhaled corticosteroid dosing table (500 μg fluticasone or equivalents for an adult)
* Asthma requiring either:
\> 1 hospitalization in the past year for asthma or \> 1 ER visit in the past 6 months for asthma
* History of intubation due to allergies or asthma
* Life-threatening allergic reaction (i.e. respiratory compromise, hypoxia, hypotension) to food(s) within last 1 year
* Diagnosis of active eosinophilic gastrointestinal disease in the past year
* Severe or poorly controlled atopic dermatitis
* Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual), immunomodulatory therapy (not including corticosteroids), or biologic therapy within the past year
* Uncontrolled hypertension
* Any use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
* Other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
40 Years
Study:
NCT01950559
Study Brief:
Protocol Section:
NCT01950559