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Completed

NCT Number: NCT05696236

Predicting Peanut Anaphylaxis and Reducing Epinephrine

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.

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Key information

Conditions

Anaphylaxis Food

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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) 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.

Primary outcomes

  1. Anaphylaxis Occurrence Rates in Each Group

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

    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.

Secondary outcomes

  1. Reaction Rates in Each Group

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

    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.

  2. Anaphylaxis Severity in Each Group

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

    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.

  3. Anaphylaxis Likelihood in Each Group Based on the Brighton Score

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

    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)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • The Gerber Foundation

Registry information

Official study title

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

Acronym: PrePARE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2023
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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