Food Hypersensitivity Clinical Trial
— DEVILOfficial title:
Determining the Efficacy and Value of Immunotherapy on the Likelihood of Peanut Tolerance: The DEVIL Study; Grant "Optimizing Tolerance Induction in Peanut Allergy: The DEVIL Study"
Verified date | February 2018 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Peanut allergy is known to cause severe anaphylactic reactions.The goal of this proposal is to produce a new treatment that would benefit young subjects who have recently been diagnosed with peanut allergy by lowering the risk of anaphylactic reactions (desensitization), and changing the peanut-specific immune response in subjects who have peanut allergy (tolerance).
Status | Completed |
Enrollment | 37 |
Est. completion date | February 1, 2017 |
Est. primary completion date | February 1, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 9 Months to 36 Months |
Eligibility |
Inclusion Criteria: - Age 9-36 months of either sex, any race, any ethnicity at the time of the initial visit - EITHER a positive skin prick test to peanuts or in vitro [CAP-FEIA] peanut immunoglobin E (IgE) level in the blood > 0.35 kU/L PLUS a history of a clinical allergic reaction (defined as significant clinical symptoms occurring within 60 minutes after ingesting peanuts) within 6 months of screening - OR a positive prick skin test to peanuts and in vitro [CAP-FEIA] peanut IgE level > 5 kU/L when there is no history of allergic reaction and no known peanut exposure - Provision of signed informed consent - Development of symptoms characteristic of IgE-mediated food allergy (urticaria, angioedema, respiratory distress/wheeze/cough, vomiting/diarrhea, anaphylaxis) during initial oral food challenge Exclusion Criteria: - History of severe anaphylaxis to peanut as defined by hypoxia, hypotension, or neurological compromise - Currently participating in a study using an investigational new drug - Participation in any interventional study for the treatment of food allergy in the past 12 months - Subjects with a known wheat food allergy will be excluded because of cross contamination of oat with wheat - Severe atopic dermatitis - Currently being treated with greater than medium daily doses of inhaled corticosteroids, as defined by the National Heart Lung and Blood Institute (NHLBI) guidelines - Inability to discontinue antihistamines for skin testing and OFCs |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Vickery BP, Berglund JP, Burk CM, Fine JP, Kim EH, Kim JI, Keet CA, Kulis M, Orgel KG, Guo R, Steele PH, Virkud YV, Ye P, Wright BL, Wood RA, Burks AW. Early oral immunotherapy in peanut-allergic preschool children is safe and highly effective. J Allergy — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine the Percentage of Subjects Who Demonstrate Sustained Unresponsiveness (SU) by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). | The goal of the study is to treat peanut-allergic subjects with peanut OIT and to determine whether this protocol lowers their risk of anaphylactic reactions and causes SU. We expect to demonstrate the effectiveness of peanut OIT in inducing SU by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT followed by avoidance of therapy for 4 weeks. | After 36 months of OIT dosing followed by 1 month of avoidance | |
Secondary | Determine the Percentage of Subjects Who Demonstrate Desensitization by a Negative Double-blind Placebo-controlled Food Challenge (DBPCFC). | We expect to demonstrate the effectiveness of peanut OIT in inducing desensitization by showing that subjects will have a negative DBPCFC to 5 grams of peanut following completion of a 36-month course of peanut OIT . | After 36 months of OIT dosing | |
Secondary | Determine the Frequency of Treatment-related Adverse Effects (TAE) From Peanut OIT. | In addition to studying the effectiveness of peanut OIT, we will also determine the safety of peanut OIT by reporting the average rate of TAEs per person per dose. | After 36 months of OIT dosing followed by 1 month of avoidance |
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