Food Allergy Challenge Diagnostic Study

Patients often discover their food allergies after consuming a given food and experiencing a
subsequent allergic reaction. The majority of patients (75%) will then consult a food
allergist for formal diagnosis and treatment information. With respect to patient quality of
life, there is tremendous benefit in having a confirmed diagnosis of food allergy as often
patients are unsure of the source of their reaction outside the office. Allergists will
conduct a Skin Prick Test (SPT) and assess serum specific IgE levels to screen for specific
food protein sensitivities. However, a positive response in SPT and specific IgE will confirm
only sensitivity, and in more than 70% of cases patients that respond positively to SPT and
specific IgE testing will NOT manifest an allergic response to food consumption. To address
this issue, most food allergists will recommend an oral food challenge in a controlled
setting to confirm the allergic response from consuming the suspected foods. The oral food
challenge (OFC) consists of consuming escalating levels of the suspect food, (usually mixed
in applesauce or controlled baked goods), until either a reaction manifests or until the
challenge is complete with no reaction. The food challenge process poses significant risk to
the patient. In 5% of cases, the patient experiences a severe allergic response which
requires the use of epinephrine. These responses typically consist of severe reactions in GI
or respiratory and arise from challenging patients with higher doses of food allergen then is
necessary to prove a mild allergic response, which is directly linked to variability in
diagnosis of a positive response, within subjects and within investigators.

The investigators hypothesize that measurements taken using minimally-invasive diagnostic
tests during the course of an escalating-dose oral food challenge will be able to detect a
positive response before a systemic reaction occurs in the patient and may be able to screen
with individuals predisposed to EOE.

Inclusion Criteria:

- Male or female of any race, aged 5 - 35 years with planned clinical oral food
challenge;

- Have provided verbal and written informed consent. If under the age of 18, a
parent/guardian must provide verbal and written informed consent;

- Be willing and able to follow instructions, including participation in study
assessments, and can be present for the required study visits for the duration of the
study;

Exclusion Criteria:

- Be unable to comply with all study parameters and procedures