Anaphylaxis FoodPrePARENCT05696236
Predicting Peanut Anaphylaxis and Reducing Epinephrine
A study testing Transepidermal water loss (TEWL) monitor and stopping rules and Monitor (TEWL) without stopping rules in people with Anaphylaxis Food, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Anaphylaxis Food
- What is being tested?
- Transepidermal water loss (TEWL) monitor and stopping rules and Monitor (TEWL) without stopping rules
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transepidermal Water Loss as a Predictor for Severe Allergic Reactions in Oral Food Challenges
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.
- Conditions
- Anaphylaxis Food
- Being tested
- Transepidermal water loss (TEWL) monitor and stopping rules, Monitor (TEWL) without stopping rules
- Keywords
- Allergic reaction to food, Water loss across the skin, Food challenge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transepidermal water loss (TEWL) monitor and stopping rulesDevice
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 rulesDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Monitor (TEWL) and stopping rules | Experimental | Wears the monitor, and the food challenge will be done using the new stopping rules to end the test. Receives: Device: Transepidermal water loss (TEWL) monitor and stopping rules |
| Monitor (TWLG) without stopping rules | Active comparator | 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. Receives: Device: Monitor (TEWL) without stopping rules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaphylaxis Occurrence Rates in Each Group
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.
Measured: Approximately 4-6 hours (Day 1 during the food challenge)
Secondary outcomes (3)
Reaction Rates in Each Group
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.
Measured: Approximately 4-6 hours (Day 1 during the food challenge)
Anaphylaxis Severity in Each Group
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.
Measured: Approximately 4-6 hours (Day 1 during the food challenge)
Anaphylaxis Likelihood in Each Group Based on the Brighton Score
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)
Measured: Approximately 4-6 hours (Day 1 during the food challenge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start23 May 2023
- Primary completion29 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaphylaxis FoodStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, Charles (Chase) Schuler, University of Michigan
- Investigators
- Chase Schuler, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696236
- Sponsor's protocol ID
- HUM00205852
- Acronym
- PrePARE
- Status last verified
- Aug 2025
- First submitted
- 13 Jan 2023
- Last updated
- 19 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Freigeh GE, O'Shea KM, Troost JP, Kaul B, Franco LM, Schuler CF 4th. Transepidermal Water Loss in Oral Food Challenges in Children With Peanut Allergy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2543371. doi: 10.1001/jamanetworkopen.2025.43371.
PubMed 41236740
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transepidermal Water Loss as a Predictor for Severe Allergic Reactions in Oral Food Challenges
- ClinicalTrials.gov ID
- NCT05696236
- Acronym / sponsor ID
- PrePARE / HUM00205852
- Conditions
- Anaphylaxis Food
- Keywords
- Allergic reaction to food, Water loss across the skin, Food challenge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- 23 May 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 25 Jan 2023 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitor (TEWL) and stopping rules | Experimental | Device: Transepidermal water loss (TEWL) monitor and stopping rulesWears the monitor, and the food challenge will be done using the new stopping rules to end the test. |
| Monitor (TWLG) without stopping rules | Active comparator | Device: Monitor (TEWL) without stopping rulesWears 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. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transepidermal water loss (TEWL) monitor and stopping rulesThe 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. | Device | Monitor (TEWL) and stopping rules |
| Monitor (TEWL) without stopping rulesThe 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. | Device | Monitor (TWLG) without stopping rules |
Primary outcome
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.
3 secondary outcomes
Reaction Rates in Each Group
Time frame: Approximately 4-6 hours (Day 1 during the food challenge)
Anaphylaxis Severity in Each Group
Time frame: Approximately 4-6 hours (Day 1 during the food challenge)
Anaphylaxis Likelihood in Each Group Based on the Brighton Score
Time frame: Approximately 4-6 hours (Day 1 during the food challenge)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41236740Freigeh GE, O'Shea KM, Troost JP, Kaul B, Franco LM, Schuler CF 4th. Transepidermal Water Loss in Oral Food Challenges in Children With Peanut Allergy: A Randomized Clinical Trial. JAMA Netw Open. 2025 Nov 3;8(11):e2543371. doi: 10.1001/jamanetworkopen.2025.43371.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chase Schuler, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transepidermal water loss (TEWL) monitor and stopping rules and Monitor (TEWL) without stopping rules in people with Anaphylaxis Food, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaphylaxis Occurrence Rates in Each Group (time frame: Approximately 4-6 hours (Day 1 during the food challenge)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.