Trial Outcomes & Findings for Predicting Peanut Anaphylaxis and Reducing Epinephrine (NCT NCT05696236)

Last Updated: 2025-08-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

Approximately 4-6 hours (Day 1 during the food challenge)

Results posted on

2025-08-19

Participant Flow

Prior to randomization, 3 participants were screen fails and 2 were lost to follow up.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	21	25
Overall Study COMPLETED	18	22
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	1	0
Overall Study Later determined to not be eligible for participation	0	1
Overall Study Withdrawal by Subject	2	2

Baseline Characteristics

Predicting Peanut Anaphylaxis and Reducing Epinephrine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Monitor (TEWL) and Stopping Rules n=21 Participants 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.	Monitor (TWLG) Without Stopping Rules n=25 Participants 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.	Total n=46 Participants Total of all reporting groups
Age, Continuous	34 months STANDARD_DEVIATION 17.2 • n=93 Participants	29 months STANDARD_DEVIATION 14.3 • n=4 Participants	31 months STANDARD_DEVIATION 15.7 • n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	12 Participants n=4 Participants	19 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	13 Participants n=4 Participants	27 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=93 Participants	23 Participants n=4 Participants	44 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	18 Participants n=93 Participants	23 Participants n=4 Participants	41 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Region of Enrollment United States	21 Participants n=93 Participants	25 Participants n=4 Participants	46 Participants n=27 Participants

PRIMARY outcome

Timeframe: Approximately 4-6 hours (Day 1 during the food challenge)

Population: 6 participants ended their participation in the trial before their data was collectible.

Outcome measures

Outcome measures
Measure	Monitor (TEWL) and Stopping Rules n=18 Participants 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.	Monitor (TWLG) Without Stopping Rules n=22 Participants 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.
Anaphylaxis Occurrence Rates in Each Group	9 Participants	10 Participants

SECONDARY outcome

Timeframe: Approximately 4-6 hours (Day 1 during the food challenge)

Population: 6 participants ended their participation in the trial before their data was collectible.

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.

Outcome measures

Outcome measures
Measure	Monitor (TEWL) and Stopping Rules n=18 Participants 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.	Monitor (TWLG) Without Stopping Rules n=22 Participants 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.
Reaction Rates in Each Group	16 Participants	14 Participants

SECONDARY outcome

Timeframe: Approximately 4-6 hours (Day 1 during the food challenge)

Population: 6 participants ended their participation in the trial before their data was collectible.

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.

Outcome measures

Outcome measures
Measure	Monitor (TEWL) and Stopping Rules n=18 Participants 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.	Monitor (TWLG) Without Stopping Rules n=22 Participants 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.
Anaphylaxis Severity in Each Group	1.8 score on a scale Standard Deviation 0.75	2.6 score on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: Approximately 4-6 hours (Day 1 during the food challenge)

Population: 6 participants ended their participation in the trial before their data was collectible.

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)

Outcome measures

Outcome measures
Measure	Monitor (TEWL) and Stopping Rules n=18 Participants 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.	Monitor (TWLG) Without Stopping Rules n=22 Participants 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.
Anaphylaxis Likelihood in Each Group Based on the Brighton Score Not Applicable	3 Participants	8 Participants
Anaphylaxis Likelihood in Each Group Based on the Brighton Score Brighton Level 1	3 Participants	2 Participants
Anaphylaxis Likelihood in Each Group Based on the Brighton Score Brighton Level 2	4 Participants	7 Participants
Anaphylaxis Likelihood in Each Group Based on the Brighton Score Brighton Level 3	2 Participants	1 Participants
Anaphylaxis Likelihood in Each Group Based on the Brighton Score Unclassified	6 Participants	4 Participants

Adverse Events

Monitor (TEWL) and Stopping Rules

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Monitor (TWLG) Without Stopping Rules

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Monitor (TEWL) and Stopping Rules n=18 participants at risk 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.	Monitor (TWLG) Without Stopping Rules n=22 participants at risk 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.
Immune system disorders Allergic Reaction	88.9% 16/18 • 24 hours	63.6% 14/22 • 24 hours

Additional Information

Charles Schuler

University of Michigan

Phone: 734-232-2154

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place