NCT01980992

Oral Immunotherapy for Wheat Allergy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hugh A Sampson, MD · Academic / Other
• Sex: All
• Age: 4 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.

Detailed description

Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.

Conditions

• Wheat Allergy

Interventions

Type	Name	Description
DRUG	Wheat OIT	Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-11-01
• Completion: 2017-04-13
• First posted: 2013-11-11
• Last updated: 2020-08-14
• Results posted: 2017-03-31

Locations

4 sites across 1 country: United States