Predicting Peanut Anaphylaxis and Reducing Epinephrine

Anaphylaxis Food Clinical Trial

— PrePARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696236
• Other study ID #: HUM00205852
• Status: Recruiting
• Phase: N/A
• Start date: May 23, 2023
• Est. completion date: March 2027

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: Christopher Launius
• Phone: 734-936-5634
• Email: cmlauniu[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anaphylaxis
• Anaphylaxis Food

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anaphylaxis occurrence rates in each group	Any Brighton Level 1, 2, or 3 anaphylaxis.	Approximately 4-6 hours (Day 1 during the food challenge)
Secondary	Reaction rates in each group	Any objective symptom of allergic reaction occurs (e.g., hives, angioedema, vomiting, wheeze, etc) not rising to the definition of anaphylaxis.	Approximately 4-6 hours (Day 1 during the food challenge)
Secondary	Anaphylaxis severity in each group	This will be 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.	Approximately 4-6 hours (Day 1 during the food challenge)
Secondary	Anaphylaxis likelihood in each group based on the Brighton score	The Brighton score gives a 0-3 score of anaphylaxis likelihood (0 = no anaphylaxis, 3 = highly likely).	Approximately 4-6 hours (Day 1 during the food challenge)