Mixed Tree Nut Food Challenges

Status unconfirmed

Conditions studied: Food Allergy

In brief

The purpose of this prospective study is twofold: 1) to establish oral tolerance to selected tree nuts and to examine potential predictors of oral tolerance and 2) to determine the usefulness of mixed tree nut allergen food challenges in more efficiently defining tree nut allergy and oral tolerance.

Key facts

Study ID

NCT02070263

Run by

Arkansas Children's Hospital Research Institute

People needed

100

Starts

2009-04-01

Expected to finish

2020-12-01

Last updated by the study team

2019-01-10

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any patient between 3-21 years of age followed by the Allergy and Immunology Department at Arkansas Children's Hospital on tree nut avoidance diet.
• Has current serum IgE test within the past 12 months to major nuts in question. All TN serum IgE are <10
• Children must have a stable baseline examination prior to undergoing challenge without significant symptoms of atopic dermatitis, allergic rhinoconjunctivitis, current urticaria or other allergic symptoms deemed important by the physician.
• Children must have stable asthma and no wheezing or repetitive cough prior to challenge, nor have been treated with oral steroids for a significant asthma exacerbation within 1 month of challenge. Asthmatics that undergo lung function testing.
• Children must have no current illness (e.g., fever or viral illness) at time of challenge.
• The subject will be asked to restrict the use of antihistamines (short acting, 72 hours: long acting, 5-7 days), (B-agonists (12 hours), theophylline (12 hours), and cromolyn (12 hours) prior to the first mixed TN food challenge. Other medications may be continued.

You may not qualify if…

• Any TN serum IgE ≥10.
• Life-threatening reaction (respiratory involvement requiring medications, or shock, or gastrointestinal reaction requiring intravenous fluids) to any TN.
• History of a reaction in the past year or severe reaction in the past 2 years or a history of a severe reaction anytime with a TN serum IgE >5
• Unstable asthma, gastrointestinal disease, cardiovascular disease, chronic lung disease, beta-blocker use.

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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