Anaphylaxis Food
Conditions
Keywords
Allergic reaction to food, Water loss across the skin, Food challenge
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.
Interventions
DEVICETransepidermal 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.
DEVICEMonitor (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.
Sponsors
The Gerber Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anaphylaxis Occurrence Rates in Each Group | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reaction Rates in Each Group | Approximately 4-6 hours (Day 1 during the food challenge) | 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. |
| Anaphylaxis Severity in Each Group | Approximately 4-6 hours (Day 1 during the 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. |
| Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Approximately 4-6 hours (Day 1 during the food challenge) | 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) |
Countries
United States
Participant flow
Pre-assignment details
Prior to randomization, 3 participants were screen fails and 2 were lost to follow up.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 25 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Later determined to not be eligible for participation | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Monitor (TEWL) and Stopping Rules | Total | Monitor (TWLG) Without Stopping Rules |
|---|---|---|---|
| Age, Continuous | 34 months STANDARD_DEVIATION 17.2 | 31 months STANDARD_DEVIATION 15.7 | 29 months STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 44 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 41 Participants | 23 Participants |
| Region of Enrollment United States | 21 Participants | 46 Participants | 25 Participants |
| Sex: Female, Male Female | 7 Participants | 19 Participants | 12 Participants |
| Sex: Female, Male Male | 14 Participants | 27 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 16 / 18 | 14 / 22 |
| serious Total, serious adverse events | 0 / 18 | 0 / 22 |
Outcome results
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.
Time frame: Approximately 4-6 hours (Day 1 during the food challenge)
Population: 6 participants ended their participation in the trial before their data was collectible.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monitor (TEWL) and Stopping Rules | Anaphylaxis Occurrence Rates in Each Group | 9 Participants |
| Monitor (TWLG) Without Stopping Rules | Anaphylaxis Occurrence Rates in Each Group | 10 Participants |
p-value: 0.77t-test, 2 sided
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)
Time frame: Approximately 4-6 hours (Day 1 during the food challenge)
Population: 6 participants ended their participation in the trial before their data was collectible.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Monitor (TEWL) and Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Not Applicable | 3 Participants |
| Monitor (TEWL) and Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Brighton Level 3 | 2 Participants |
| Monitor (TEWL) and Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Brighton Level 1 | 3 Participants |
| Monitor (TEWL) and Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Unclassified | 6 Participants |
| Monitor (TEWL) and Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Brighton Level 2 | 4 Participants |
| Monitor (TWLG) Without Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Unclassified | 4 Participants |
| Monitor (TWLG) Without Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Not Applicable | 8 Participants |
| Monitor (TWLG) Without Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Brighton Level 2 | 7 Participants |
| Monitor (TWLG) Without Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Brighton Level 3 | 1 Participants |
| Monitor (TWLG) Without Stopping Rules | Anaphylaxis Likelihood in Each Group Based on the Brighton Score | Brighton Level 1 | 2 Participants |
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.
Time frame: Approximately 4-6 hours (Day 1 during the food challenge)
Population: 6 participants ended their participation in the trial before their data was collectible.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Monitor (TEWL) and Stopping Rules | Anaphylaxis Severity in Each Group | 1.8 score on a scale | Standard Deviation 0.75 |
| Monitor (TWLG) Without Stopping Rules | Anaphylaxis Severity in Each Group | 2.6 score on a scale | Standard Deviation 0.51 |
p-value: 0.006t-test, 2 sided
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.
Time frame: Approximately 4-6 hours (Day 1 during the food challenge)
Population: 6 participants ended their participation in the trial before their data was collectible.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Monitor (TEWL) and Stopping Rules | Reaction Rates in Each Group | 16 Participants |
| Monitor (TWLG) Without Stopping Rules | Reaction Rates in Each Group | 14 Participants |
p-value: 0.07t-test, 2 sided