Mechanisms Underlying Peanut Allergic Reactions in TRACE Peanut Study Participants: Extension Study (TRACEextension)
Food Hypersensitivity, Peanut Hypersensitivity
About this trial
This is an interventional other trial for Food Hypersensitivity focused on measuring Peanut allergy, Food allergy, Thresholds, Anaphylaxis
Eligibility Criteria
Inclusion Criteria:
- Written informed consent.
- Male and female participants in the TRACE study (NCT01429896) who are 18-45 years of age at the time of entry to the TRACE study (Visit 1) and had a positive DBPCFC to peanut at baseline (Visit 1).
Exclusion criteria
- unable to comply with study procedures
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
DBPCFC to peanut cookie, then single-dose DBPCFC x 2
Single dose DBPCFC x 2, then DBPCFC to peanut cookie
Patients will undergo 3 sets of double-blind, placebo-controlled food challenge (DBPCFC): DBPCFC to incremental doses of peanut (or placebo) baked into a cookie biscuit DBPCFC to a single dose of peanut (or placebo) equivalent to 1 dosing interval below that to which that patient reacted at the baseline DBPCFC to gain entry to the study, on two separate occasions
Patients will undergo 3 sets of double-blind, placebo-controlled food challenge (DBPCFC): DBPCFC to a single dose of peanut (or placebo) equivalent to 1 dosing interval below that to which that patient reacted at the baseline DBPCFC to gain entry to the study, on two separate occasions DBPCFC to incremental doses of peanut (or placebo) baked into a cookie biscuit