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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transepidermal water loss (TEWL) monitor and stopping rules | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 4-6 hours (Day 1 during the food challenge) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Approximately 4-6 hours (Day 1 during the food challenge) |
| Anaphylaxis Severity in Each Group |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chase Schuler, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41236740 | Derived | 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. |
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Prior to randomization, 3 participants were screen fails and 2 were lost to follow up.
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| ID | Title | Description |
|---|---|---|
| FG000 | Monitor (TEWL) and Stopping Rules | Wears the monitor, and the food challenge will be done using the new stopping rules to end the test. 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. |
| FG001 | Monitor (TWLG) Without Stopping Rules | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Monitor (TEWL) and Stopping Rules | Wears the monitor, and the food challenge will be done using the new stopping rules to end the test. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 6 participants ended their participation in the trial before their data was collectible. | Posted | Count of Participants | Participants | Approximately 4-6 hours (Day 1 during the food challenge) |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Monitor (TEWL) and Stopping Rules | Wears the monitor, and the food challenge will be done using the new stopping rules to end the test. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | Systematic Assessment | All reactions were food allergy reactions up to food anaphylaxis. There is no single definition for food anaphylaxis, so all food-reaction adverse events are reported here. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Schuler | University of Michigan | 734-232-2154 | schulerc@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2023 | Jul 15, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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| Monitor (TEWL) without stopping rules | Device | 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. |
|
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. |
| 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) | Approximately 4-6 hours (Day 1 during the food challenge) |
| Withdrawal by Subject |
|
| BG001 | Monitor (TWLG) Without Stopping Rules | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Monitor (TWLG) Without Stopping Rules | 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. 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. |
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| Secondary | 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. | 6 participants ended their participation in the trial before their data was collectible. | Posted | Count of Participants | Participants | Approximately 4-6 hours (Day 1 during the food challenge) |
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| Secondary | 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. | 6 participants ended their participation in the trial before their data was collectible. | Posted | Mean | Standard Deviation | score on a scale | Approximately 4-6 hours (Day 1 during the food challenge) |
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| Secondary | 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) | 6 participants ended their participation in the trial before their data was collectible. | Posted | Count of Participants | Participants | Approximately 4-6 hours (Day 1 during the food challenge) |
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| 0 |
| 18 |
| 0 |
| 18 |
| 16 |
| 18 |
| EG001 | Monitor (TWLG) Without Stopping Rules | 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. 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. | 0 | 22 | 0 | 22 | 14 | 22 |
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| Brighton Level 2 |
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| Brighton Level 3 |
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| Unclassified |
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