Back to resultsPredicting Peanut Anaphylaxis and Reducing Epinephrine (PrePARE)
Primary Purpose
Anaphylaxis Food
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transepidermal water loss (TEWL) monitor and stopping rules
Monitor (TEWL) without stopping rules
Sponsored by
About this trial
This is an interventional diagnostic trial for Anaphylaxis Food focused on measuring Allergic reaction to food, Water loss across the skin, Food challenge
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.
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Monitor (TEWL) and stopping rules
Monitor (TWLG) without stopping rules
Arm Description
Wears the monitor, and the food challenge will be done using the new stopping rules to end the test.
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.
Outcomes
Primary Outcome Measures
Anaphylaxis occurrence rates in each group
Any Brighton Level 1, 2, or 3 anaphylaxis.
Secondary Outcome Measures
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.
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.
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).
Full Information
NCT ID
NCT05696236
First Posted
January 13, 2023
Last Updated
September 20, 2023
Sponsor
University of Michigan
Collaborators
The Gerber Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05696236
Brief Title
Predicting Peanut Anaphylaxis and Reducing Epinephrine
Acronym
PrePARE
Official Title
Transepidermal Water Loss as a Predictor for Severe Allergic Reactions in Oral Food Challenges
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
The Gerber Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaphylaxis Food
Keywords
Allergic reaction to food, Water loss across the skin, Food challenge
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Participants and families, the food allergy nurse administering the oral food challenge (OFC), and the allergist physician assessing and treating the patient will be blinded to the study arm status.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monitor (TEWL) and stopping rules
Arm Type
Experimental
Arm Description
Wears the monitor, and the food challenge will be done using the new stopping rules to end the test.
Arm Title
Monitor (TWLG) without stopping rules
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transepidermal water loss (TEWL) monitor and stopping rules
Intervention Description
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
Intervention Name(s)
Monitor (TEWL) without stopping rules
Intervention Description
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 Outcome Measure Information:
Title
Anaphylaxis occurrence rates in each group
Description
Any Brighton Level 1, 2, or 3 anaphylaxis.
Time Frame
Approximately 4-6 hours (Day 1 during the food challenge)
Secondary Outcome Measure Information:
Title
Reaction rates in each group
Description
Any objective symptom of allergic reaction occurs (e.g., hives, angioedema, vomiting, wheeze, etc) not rising to the definition of anaphylaxis.
Time Frame
Approximately 4-6 hours (Day 1 during the food challenge)
Title
Anaphylaxis severity in each group
Description
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.
Time Frame
Approximately 4-6 hours (Day 1 during the food challenge)
Title
Anaphylaxis likelihood in each group based on the Brighton score
Description
The Brighton score gives a 0-3 score of anaphylaxis likelihood (0 = no anaphylaxis, 3 = highly likely).
Time Frame
Approximately 4-6 hours (Day 1 during the food challenge)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Launius
Phone
734-936-5634
Email
cmlauniu@umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bridgette Kaul
Phone
734-963-5634
Email
bbeaupre@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chase Schuler, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Launius
Phone
734-936-5634
Email
cmlauniu@umich.edu
First Name & Middle Initial & Last Name & Degree
Bridgette Kaul
Phone
734-963-5634
Email
bbeaupre@umich.edu
First Name & Middle Initial & Last Name & Degree
Chase Schuler, MD
First Name & Middle Initial & Last Name & Degree
Kelly O'Shea, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Predicting Peanut Anaphylaxis and Reducing Epinephrine
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