Predicting Peanut Anaphylaxis and Reducing Epinephrine (PrePARE)

University of Michigan

Status: Completed

Conditions: Anaphylaxis Food

Treatments: Device: Monitor (TEWL) without stopping rules; Device: Transepidermal water loss (TEWL) monitor and stopping rules

Study type: Interventional

Funder types: Other

Identifiers

NCT05696236

HUM00205852

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Monitor (TEWL) and stopping rules

Experimental group

Description:

Wears the monitor, and the food challenge will be done using the new stopping rules to end the test.

Treatment:

Device: Transepidermal water loss (TEWL) monitor and stopping rules

Monitor (TWLG) without stopping rules

Active Comparator group

Description:

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.

Treatment:

Device: Monitor (TEWL) without stopping rules