Clinical trial NCT01980992: Oral Immunotherapy for Wheat Allergy
Official title: Oral Immunotherapy for Wheat Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Wheat Allergy
Keywords: Food Allergy
Wheat Allergy
Oral Immunotherapy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 46
Sex: ALL
Minimum age (years): 4
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.
timeFrame: 1 Year
Secondary outcomes:
measure: Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge
timeFrame: 8 to 10 weeks after passing the 2 Year OFC
measure: Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT
timeFrame: 44 Weeks
measure: Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group
timeFrame: 2 Years
measure: Incidence of All Serious Adverse Events During the Study.
timeFrame: 1 year and 2 Years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Hugh A Sampson, MD
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai
name: Hugh A Sampson, MD
role: PRINCIPAL_INVESTIGATOR
References: