Wheat Allergy Clinical Trial
— Wheat OITOfficial title:
Oral Immunotherapy for Wheat Allergy
Verified date | August 2020 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | April 13, 2017 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 30 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
United States | Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Hugh A Sampson, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment. | 1 Year | |
Secondary | Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge | The number of subjects who successfully consume a 7443 mg wheat protein oral food challenge (OFC) 8-10 weeks after therapy discontinuation and after passing the 7443 mg wheat protein OFC at the 2 year time point.This OFC will only be administered to subjects in the initial active treatment group. | 8 to 10 weeks after passing the 2 Year OFC | |
Secondary | Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT | The number of subjects who achieve the targeted maintenance dose of wheat OIT during the desensitization phase of the study. For Wheat OIT group, reached target dose of 2035 mg wheat powder/1445 mg wheat protein. For placebo group, reached target dose of 2035 mg placebo powder. | 44 Weeks | |
Secondary | Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group | The number of subjects that achieve desensitization in the placebo cross over group after 1 year of dosing. Able to consume at least 4443 mg wheat protein on the Week 52 Crossover OFC (4443 mg wheat protein is the amount that was used for the primary endpoint). | 2 Years | |
Secondary | Incidence of All Serious Adverse Events During the Study. | 1 year and 2 Years |
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