Oral Immunotherapy for Wheat Allergy

Launched by HUGH A SAMPSON, MD · Nov 5, 2013

Keywords

ClinConnect Summary

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 re...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 4-30 years either sex, any race, any ethnicity
• • Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE \>= 0.35 kUA/L
• • Positive baseline challenge to wheat (\<= 1923 mg of vital wheat gluten)
• • Written informed consent from subject and/or parent/guardian
• • Written assent from all subjects as appropriate
• • All females of child bearing age must be using appropriate birth control
• Exclusion Criteria:
• • History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation
• • Known allergy to corn
• • Known celiac disease
• • Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
• • Active eosinophilic gastrointestinal disease in the past two years
• • Participation in any interventional study for the treatment of food allergy in the past 6 months
• • Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
• • Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
• • A burst of oral, IM or IV steroids of more than 2 days for an indication other than asthma in the past 1 month
• • Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
• • Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
• • Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
• • Use of investigational drug within 90 days or plan to use investigational drug during the study period
• • Pregnancy or lactation