Walnut Oral Immunotherapy for Tree Nut Allergy (NCT01546753) | Clinical Trial Compass
CompletedPhase 1/2
Walnut Oral Immunotherapy for Tree Nut Allergy
United States22 participantsStarted 2012-04-27
Plain-language summary
The purpose of this study is to determine if walnut oral immunotherapy can be used in participants allergic to tree nuts to reduce tree nut allergy and induce changes in the participant's immune system.
Who can participate
Age range6 Years – 45 Years
SexALL
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Inclusion Criteria:
* Age 6 to 45 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 nut.
* A positive 2000 mg oral food challenge at enrollment to walnut and to one other tree nut.
* Written informed consent from participant and/or parent/guardian
* Written assent from all subjects as appropriate
* All females of child bearing age must be using appropriate birth control
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 the 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 …
What they're measuring
1
Effectiveness of Walnut OIT on Clinical Desensitization to Test Tree Nut as Measured by Change in Cumulative Tolerated Dose From Baseline to Week 38 at Oral Food Challenge