Mixed Tree Nut Food Challenges

NCT02070263 | Unknown

• 1 other identifier: 110035
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Allergy

Keywords

Food allergy; Tree nuts

Outcome Measures

Primary Outcomes (1)

• Oral tolerance to selected tree nuts (TN) to determine potential predictors of oral tolerance.

  This prospective, observational study uses serum IgE to specific TN, skin prick test to TN, and TN oral food challenges to establish oral tolerance.

  total -20 years

Secondary Outcomes (1)

• Use of tree nut (TN) IgE testing to assess the risk of positive food challenges based on grouped mixed TN food challenges

  total - 20 years

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen at Arkansas Children's Hospital between 3-21 years of age who have tree nut food allergies.

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.

Sponsors & Collaborators

• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Stacie M Jones, MD

  University of Arkansas for Medical Sciences / Arkansas Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: February 25, 2014
• Study Start: April 1, 2009
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

US (1)