Predicting Peanut Anaphylaxis and Reducing Epinephrine (PrePARE)

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

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.

Study Overview

• Status: Completed
• Conditions: Anaphylaxis Food
• Intervention / Treatment: Device: Transepidermal water loss (TEWL) monitor and stopping rules; Device: Monitor (TEWL) without stopping rules

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monitor (TEWL) and stopping rules; Wears the monitor, and the food challenge will be done using the new stopping rules to end the test.	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.
Active Comparator: Monitor (TWLG) 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anaphylaxis Occurrence Rates in Each Group	Any Brighton Level 1, 2, or 3 anaphylaxis. The Brighton Level is a system for classifying the severity and diagnostic certainty of anaphylaxis cases, particularly in the context of adverse events following immunization. Results reflect the number of participants who experienced any of the Brighton Level 1, 2, or 3 anaphylaxis events.	Approximately 4-6 hours (Day 1 during the food challenge)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reaction Rates in Each Group	Results reflect the number of participants who experienced any objective symptom of allergic reaction (e.g., hives, angioedema, vomiting, wheeze, etc) not rising to the definition of anaphylaxis.	Approximately 4-6 hours (Day 1 during the food challenge)
Anaphylaxis Severity in Each Group	Anaphylaxis severity was 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.	Approximately 4-6 hours (Day 1 during the food challenge)
Anaphylaxis Likelihood in Each Group Based on the Brighton Score	The Brighton score was a 1-3 score of anaphylaxis likelihood. Participants were categorized based on level of anaphylaxis likelihood: Not Applicable (no reaction), Brighton Level 1 (most likely), Brighton Level 2 (medium likelihood), Brighton Level 3 (least likely), Unclassified (reaction present, but with insufficient symptoms for participant's reaction to be classified)	Approximately 4-6 hours (Day 1 during the food challenge)

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: The Gerber Foundation
• Investigators: Principal Investigator: Chase Schuler, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2023
• Primary Completion (Actual): August 29, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Allergic reaction to food; Water loss across the skin; Food challenge
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Anaphylaxis; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Tin Fluorides
• Other Study ID Numbers: HUM00205852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No