Predicting Peanut Anaphylaxis and Reducing Epinephrine
- Conditions
- Anaphylaxis Food
- Interventions
- Device: Transepidermal water loss (TEWL) monitor and stopping rulesDevice: Monitor (TEWL) without stopping rules
- Registration Number
- NCT05696236
- Lead Sponsor
- University of Michigan
- Brief Summary
This research study is testing a new way to look for the early stages of anaphylaxis. Eligible participants will have a small monitor (transepidermal water loss) placed on the forearm during a food challenge (for peanut allergies). This monitor continuously records the amount of water lost through the skin.
In a previous study the team learned what values are associated with an anaphylactic reaction. These values are called "stopping rules." This study is looking at whether it can use these new stopping rules to end the oral food challenge before a person may show any symptoms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Have a known history of food anaphylaxis to peanut confirmed by an allergist
- Have had skin and blood food allergy testing to peanut within the past 12 months. Meet the 80% likelihood positive predictive value threshold for peanut allergy based on at least 1 of either the skin or blood immunoglobulin E (IgE) tests per current literature corrected for age.
- Meet all clinical oral food challenge (OFC) requirements. This includes no asthma or atopic dermatitis exacerbations, no recent viral infections, no recent antibiotics, and no food allergy reactions in the past month.
- Any known cardiovascular disease, cancer, pulmonary disease except well-controlled asthma, or other condition that would preclude an OFC otherwise.
- Any medication use that would interfere with an OFC result. Medications in this category include antihistamines (first or second generation) within 1 week, omalizumab within 3 months, and others listed in the protocol appendix.
- Any skin condition aside from well-controlled eczema that might impact TEWL measurement, including such conditions as autoimmune skin conditions (such as psoriasis), congenital ichthyoses, hyper-IgE syndromes.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Monitor (TEWL) and stopping rules Transepidermal water loss (TEWL) monitor and stopping rules Wears the monitor, and the food challenge will be done using the new stopping rules to end the test. Monitor (TWLG) without stopping rules Monitor (TEWL) without stopping rules Wears the monitor, but the stopping rules will not be used to end the food challenge. The food challenge will be done following standard oral food challenge procedures.
- Primary Outcome Measures
Name Time Method Anaphylaxis occurrence rates in each group Approximately 4-6 hours (Day 1 during the food challenge) Any Brighton Level 1, 2, or 3 anaphylaxis.
- Secondary Outcome Measures
Name Time Method Reaction rates in each group Approximately 4-6 hours (Day 1 during the food challenge) Any objective symptom of allergic reaction occurs (e.g., hives, angioedema, vomiting, wheeze, etc) not rising to the definition of anaphylaxis.
Anaphylaxis severity in each group Approximately 4-6 hours (Day 1 during the food challenge) This will be graded on a scale of 1 to 5 (where 1 = mild, 5 = death)) according to criteria set forth in the Consortium for Food Allergy Research (CoFAR) Grading Scale.
Anaphylaxis likelihood in each group based on the Brighton score Approximately 4-6 hours (Day 1 during the food challenge) The Brighton score gives a 0-3 score of anaphylaxis likelihood (0 = no anaphylaxis, 3 = highly likely).
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States