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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT01918657
Eligibility Criteria:
Inclusion Criteria:
* Age 6 to 21 years, either sex, any race, any ethnicity with a convincing clinical history of walnut or another tree nut allergy and either a positive prick skin test (\>3mm) or serologic evidence of allergic sensitization (defined as specific IgE\>0.35 kU/L) to walnut and at least one other tree.
* A positive \<2000 mg protein oral food challenge at enrollment to walnut and to one other tree nut.
* Written informed consent from participant and/or parent/guardian, including assent where indicated.
* All females of child-bearing age must be using appropriate birth control or practicing abstinence.
Exclusion Criteria:
* History of severe anaphylaxis to walnut or other tree nuts, defined as symptoms associated with hypoxia, hypotension or neurologic compromise (cyanosis or SpO2\<92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence).
* Known allergy to oat
* Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy or other respiratory or medical conditions deemed by the investigator to put subject at increased risk of anaphylaxis or poor outcomes from receiving OIT or undergoing food challenge.
* Poor control or persistent activation of atopic dermatitis
* Active eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease in the past 2 years.
* Participation in any interventional study for food allergy in the past 6 months
* Participant is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing).
* Severe asthma (2007 NHLBI Criteria Steps 5 or 6, see Appendix 2)
* Mild or moderate (2007 NHLBI Criteria Steps 1-4) asthma with any of the following criteria met:
* FEV1 \< 80% of predicted, or FEV1/FVC \< 75%, with or without controller medications or
* ICS dosing of \> 500 mcg daily fluticasone (or equivalent inhaled corticosteroids based on NHLBI dosing chart) or
* History of daily oral steroid dosing for \> 1 month during the past year or
* Burst of oral, IM, or IV steroids for \>3 days in the past 6 months for asthma control or
* \> 1 burst of oral, IM or IV steroids in the past year for asthma control or
* \> 1 hospitalization in the past year for asthma or
* \> 1 ER visit in the past 6 months for asthma
* Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
* Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
* Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
21 Years
Study:
NCT01918657
Study Brief:
Protocol Section:
NCT01918657