Understanding How the Immune System Responds to Viruses in Peanut Allergic Children Undergoing Peanut Oral Immunotherapy

Completed · Not applicable

Conditions studied: Peanut Allergy

In brief

The purpose of this study is to find out if there is a way to treat children with peanut allergy to help lower the risk of severe allergic reactions and also cause them to lose their allergy to peanuts and to understand what happens to their immune systems when they have viral infections while on therapy. The approach we will use to treat peanut allergy in this study is a process called desensitization. We think that children with a peanut allergy receiving peanut oral immunotherapy will be able to eat more peanuts without having a reaction by the end of the study than they could eat at the beginning. We also think that we will be able to measure changes in their immune system and their immune system's response to viruses while they are on therapy.

Key facts

Study ID

NCT01074840

Run by

University of Texas Southwestern Medical Center

People needed

12

Starts

2010-02-01

Expected to finish

2014-08-01

Last updated by the study team

2014-12-03

Who can join

Age: 3 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 3 to 16 years of either sex, any race, any ethnicity, weighing at least 18.3 kg at the time of the initial visit.
• The presence of IgE specific to peanuts (a positive skin prick test to peanuts (diameter of wheal > 3.0 mm) and a positive in vitro IgE (CAP-FEIA) > 7 kU/L) measured within the past year.
• Significant clinical symptoms occurring within 60 minutes after ingesting peanuts during an observed Double-Blind Placebo Controlled Food Challenge.
• Provide signed informed consent.
• Ability to follow-up regularly for scheduled appointments.
• Females of child-bearing potential must be willing to practice an acceptable form of birth control throughout the protocol.

You may not qualify if…

• History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise (Cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence)
• Currently participating in a study using an investigational new drug.
• Participation in any interventional study for the treatment of food allergy in the past 12 months or while participating in this study.
• Subjects with a known oat or wheat (because of potential cross contamination with oat) food allergy will be excluded
• Poor control or persistent activation of atopic dermatitis.
• Diagnosis of asthma and currently being treated with daily doses of inhaled corticosteroids or requiring a rescue inhaler more than 2 days per week.
• Inability to discontinue antihistamines for skin testing and Oral Food Challenges (OFCs).
• Pregnant female.
• Chronic medical condition requiring frequent use of oral steroids, chronic psychiatric illness or history of substance abuse.

Where it is running

• Children's Medical Center Dallas Food Allergy Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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