N/A
N=46
Predicting Peanut Anaphylaxis and Reducing Epinephrine
Anaphylaxis Food
Bottom Line
View on ClinicalTrials.gov: NCT05696236 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Anaphylaxis Occurrence Rates in Each Group — 9; 10 Participants — p=0.77
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transepidermal water loss (TEWL) monitor and stopping rules (Device); Monitor (TEWL) without stopping rules (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anaphylaxis Occurrence Rates in Each Group |
9; 10 | 0.77 |
| SECONDARY Reaction Rates in Each Group |
16; 14 | 0.07 |
| SECONDARY Anaphylaxis Severity in Each Group |
1.8; 2.6 | 0.006 sig |
| SECONDARY Anaphylaxis Likelihood in Each Group Based on the Brighton Score |
3; 8; 3; 2; 4; 7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05696236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.