Mixed Tree Nut Food Challenges

Food Allergy Clinical Trial

Official title:

Mixed Tree Nut Food Challenges

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02070263
• Other study ID #: 110035
• Status: Enrolling by invitation
• Start date: April 2009
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

To evaluate the absence of tree nuts (TN) allergy, referred patients from one of the Arkansas Children's Hospital (ACH) Allergy Clinic physicians with current serum immunoglobulin E (IgE) to TNs that meet eligibility criteria will be invited to undergo a series of open mixed TN food challenges.

A questionnaire pertaining to their TN allergy will be administered

A brief physical exam will be performed.

Skin prick tests using selected nut allergen extracts along with a positive (histamine) and a negative (salt-water) control will be performed at the first oral food challenge visit.

Each food challenges will be performed to 1 to 3 TNs.

Two telephone follow-up phone calls will evaluate inclusion/exclusion of tree nuts in the diet post food challenge.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Use of tree nut (TN) IgE testing to assess the risk of positive food challenges based on grouped mixed TN food challenges	We postulate that by grouping TN that are mixed into one food challenge based on the individual's TN serum IgE will be more efficient in defining TN allergy and tolerance. One to three TNs will be in one food challenge based on TN IgE testing.	total - 20 years