Predicting Peanut Anaphylaxis and Reducing Epinephrine

NCT05696236 | Completed Results FDA Device

• 1 other identifier: HUM00205852
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Anaphylaxis Food

Keywords

Allergic reaction to food; Water loss across the skin; Food challenge

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reaction Rates in Each Group

  Approximately 4-6 hours (Day 1 during the food challenge)

• Anaphylaxis Severity in Each Group

  Approximately 4-6 hours (Day 1 during the food challenge)

• Anaphylaxis Likelihood in Each Group Based on the Brighton Score

  Approximately 4-6 hours (Day 1 during the food challenge)

Study Arms (2)

Monitor (TEWL) and stopping rules

EXPERIMENTAL

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

Monitor (TWLG) without stopping rules

ACTIVE COMPARATOR

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

Interventions

Transepidermal water loss (TEWL) monitor and stopping rules DEVICE

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.

Monitor (TEWL) and stopping rules

Monitor (TEWL) without stopping rules DEVICE

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.

Monitor (TWLG) without stopping rules

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• The Gerber Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Freigeh GE, O'Shea KM, Troost JP, Kaul B, Franco LM, Schuler CF 4th. Transepidermal Water Loss in Oral Food Challenges in Children With Peanut Allergy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2543371. doi: 10.1001/jamanetworkopen.2025.43371.

  PMID: 41236740 DERIVED

MeSH Terms

Interventions

Monitoring, Physiologic

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Charles Schuler
• Organization: University of Michigan

schulerc@med.umich.edu

734-232-2154

Study Officials

• Chase Schuler, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants and families, the food allergy nurse administering the oral food challenge (OFC), and the allergist physician assessing and treating the patient will be blinded to the study arm status.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Allergy and Clinical Immunology and Assistant Professor of Mary H Weiser Food Allergy

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: May 23, 2023
• Primary Completion: August 29, 2024
• Study Completion: August 30, 2024
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)