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Mixed Tree Nut Food Challenges

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ClinicalTrials.gov Identifier: NCT02070263
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2014
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

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.

Condition or disease
Food Allergy

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Mixed Tree Nut Food Challenges
Study Start Date : April 2009
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Oral tolerance to selected tree nuts (TN) to determine potential predictors of oral tolerance. [ Time Frame: total -20 years ]
    This prospective, observational study uses serum IgE to specific TN, skin prick test to TN, and TN oral food challenges to establish oral tolerance.


Secondary Outcome Measures :
  1. Use of tree nut (TN) IgE testing to assess the risk of positive food challenges based on grouped mixed TN food challenges [ Time Frame: total - 20 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070263


Locations
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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
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Principal Investigator: Stacie M Jones, MD University of Arkansas for Medical Sciences / Arkansas Children's Hospital

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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02070263     History of Changes
Other Study ID Numbers: 110035
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data has not been analyzed at thistime

Keywords provided by Arkansas Children's Hospital Research Institute:
Food allergy
Tree nuts

Additional relevant MeSH terms:
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Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases