Predicting Peanut Anaphylaxis and Reducing Epinephrine

NCT ID: NCT05696236

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-23
• Study Completion Date: 2024-08-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Monitor (TEWL) and stopping rules

Wears the monitor, and the food challenge will be done using the new stopping rules to end the test.

Group Type: EXPERIMENTAL

Transepidermal water loss (TEWL) monitor and stopping rules

Intervention Type: 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 (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.

Group Type: ACTIVE_COMPARATOR

Monitor (TEWL) without stopping rules

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

The Gerber Foundation

OTHER

Sponsor Role: collaborator

Responsible Party

Charles (Chase) Schuler

Assistant Professor of Allergy and Clinical Immunology and Assistant Professor of Mary H Weiser Food Allergy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chase Schuler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00205852

Identifier Type: -

Identifier Source: org_study_id