20 Participants NeededMy employer runs this trial

Zileuton for Food Allergy

AL
MC
Overseen ByMichelle Catalano, BS, LPN
Age: < 18
Sex: Any
Trial Phase: Phase 1
Sponsor: Abigail Lang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Our proposed project will seek to determine if an oral medication called zileuton, which blocks the synthesis of inflammatory molecules called leukotrienes that are involved in allergic reactions, may be able to decrease absorption of food allergens and prevent severe food allergy reactions from occurring. Our study will measure levels of peanut in the blood before and after subjects consume an allergen they can tolerate and compare the results with and without administration of the study medication, zileuton. If our study shows that zileuton can decrease the absorption of a food allergen, this will allow us to see if this medication can be used to prevent anaphylaxis to food.

The goal of this proof-of-concept study is to determine whether zileuton inhibits food allergen absorption in children and adolescents with food allergy. The main questions it aims to answer are:

* Does zileuton administration impact food allergen absorption in children and adolescents with food allergies?

* What is the variability of food allergen absorption in children and adolescents with IgE-mediated food allergies?

Researchers will compare levels of peanut allergen proteins in the participants' blood with and without a dose of zileuton prior to a test meal of peanut protein.

* Visit 1 will involve a baseline blood draw, a test meal of peanut protein and a post-meal blood draw.

* Visit 2 will involve a baseline blood draw, a dose of zileuton before the test meal of peanut protein, and blood draws after the test meal.

Are You a Good Fit for This Trial?

This trial is for children and teens with IgE-mediated food allergies, such as peanut allergy. Participants must be able to safely eat a small amount of the test allergen under medical supervision.

Inclusion Criteria

Parent or guardian fluent in English
Known IgE-mediated food allergy other than peanut confirmed by clinical history of reaction to the food antigen plus positive skin prick testing and/or serum food-specific IgE and confirmation of the food allergy diagnosis by a board-certified allergist
I am between 12 and 17 years old.

Exclusion Criteria

Non-English speaking participants
Previous positive peanut specific IgE test or skin prick test, or a history of any allergic symptoms following peanut consumption
Previous hypersensitivity or anaphylaxis to zileuton
See 13 more

What Are the Treatments Tested in This Trial?

Interventions

  • Zileuton extended release

Trial Overview

The study tests whether zileuton (an oral medication) can reduce how much of a food allergen gets absorbed after eating it. Each participant will try the test meal both with and without taking zileuton beforehand, in a controlled setting.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Study treatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Abigail Lang

Lead Sponsor