FARE Clinical Trial Finder
Walnut Oral Immunotherapy for Tree Nut Allergy
The purpose of this study is to determine if walnut oral immunotherapy can be used in subjects allergic to tree nuts to reduce tree nut allergy and induce changes in the subject's immune system.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||6 Years - 45 Years|
- - 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 not reached maintenance dosing).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Arkansas|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Stacie M Jones, MD|
|Principal Investigator Affiliation||University of Arkansas for Medical Sciences / Arkansas Children's Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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Arkansas Children's Hospital
Little Rock, Arkansas, 72202