CompletedNot Applicable

Predicting Peanut Anaphylaxis and Reducing Epinephrine

United States51 participantsStarted 2023-05-23

Plain-language 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.

Who can participate

Age range

6 Months – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anaphylaxis Occurrence Rates in Each Group

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

Trial details

NCT IDNCT05696236

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-29

Results submitted2025-07-29

View on ClinicalTrials.gov More Anaphylaxis Food trials