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Predicting Peanut Anaphylaxis and Reducing Epinephrine

NCT05696236 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-08-19

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Chase Schuler, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-23
Primary Completion
2024-08-29
Completion
2024-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05696236 on ClinicalTrials.gov