Clinical trial NCT05696236: Predicting Peanut Anaphylaxis and Reducing Epinephrine
Official title: Transepidermal Water Loss As a Predictor for Severe Allergic Reactions in Oral Food Challenges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anaphylaxis Food
Keywords: Allergic reaction to food
Water loss across the skin
Food challenge
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2023-01-25
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anaphylaxis occurrence rates in each group
timeFrame: Approximately 4-6 hours (Day 1 during the food challenge)
Secondary outcomes:
measure: Reaction rates in each group
timeFrame: Approximately 4-6 hours (Day 1 during the food challenge)
measure: Anaphylaxis severity in each group
timeFrame: Approximately 4-6 hours (Day 1 during the food challenge)
measure: Anaphylaxis likelihood in each group based on the Brighton score
timeFrame: Approximately 4-6 hours (Day 1 during the food challenge)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Chase Schuler, MD
role: PRINCIPAL_INVESTIGATOR
References: