Clinical Trial: Food Allergy Challenge Diagnostic Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: An Exploratory Pilot Study Evaluating Various Diagnostic Measurements Taken During an Escalating Dose Oral Food Challenge to Patient Response
Brief Summary: The objective of this study is to correlate various diagnostic measurements taken during an escalating dose oral food challenge to the subject's response. This study will investigate whether non invasive objective biomarkers can indicate a positive response to an escalating dose OFC before a systemic reaction occurs.
Detailed Summary:
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 resp
Sponsor: ORA, Inc.
Current Primary Outcome:
- Correlation between objective biomarker measures and challenge outcome [ Time Frame: Change from baseline at 15 minute intervals until completion of challenge (approximately 3 hours) ]Correlation between imaging measurements taken before, during, and after oral food challenge to outcome of challenge
- Correlation between subjective biomarker measures and challenge outcome [ Time Frame: Change from baseline at 15 minute intervals until completion of challenge (approximately 3 hours) ]Correlation between symptom questionnaire taken before, during, and after oral food challenge to outcome of challenge
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: ORA, Inc.
Dates:
Date Received: November 10, 2015
Date Started: March 2016
Date Completion: October 2016
Last Updated: May 11, 2016
Last Verified: May 2016
