NCT05696236

Predicting Peanut Anaphylaxis and Reducing Epinephrine

Transepidermal Water Loss as a Predictor for Severe Allergic Reactions in Oral Food Challenges

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anaphylaxis Food

Interventions

Type	Name	Description
DEVICE	Transepidermal water loss (TEWL) monitor and stopping rules	The oral food challenge will be done as usual, and participants will wear the TEWL monitor. The research food allergy nurse and doctor will also be looking for signs and symptoms of an allergic reaction. The research study coordinator will be watching the TEWL numbers. If they numbers match the stopping rules, they will tell the doctor and the oral food challenge will be over.
DEVICE	Monitor (TEWL) without stopping rules	The oral food challenge will be done as usual, and participants will wear the TEWL monitor. The research food allergy nurse and doctor will be looking for signs and symptoms of an allergic reaction. The research study coordinator will be watching the TEWL numbers, but the stopping rules will not be used to end the oral food challenge.

Timeline

• Start date: 2023-05-23
• Primary completion: 2024-08-29
• Completion: 2024-08-30
• First posted: 2023-01-25
• Last updated: 2025-08-19
• Results posted: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study