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Behavioural Intervention

TEWL Monitoring for Peanut Allergy Anaphylaxis Prevention (PrePARE Trial)

N/A
Recruiting
Led By Chase Schuler, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4-6 hours (day 1 during the food challenge)
Awards & highlights

Summary

This trial tests a new way to detect early signs of anaphylaxis in peanut allergy patients during food challenges. It uses a sensor to monitor skin water loss to end the challenge before symptoms appear.

Who is the study for?
This trial is for people with a confirmed peanut allergy by an allergist, who've had recent skin and blood tests. They should be likely to have a peanut allergy based on these tests and fit the criteria for an oral food challenge, which means no recent asthma attacks or infections.
What is being tested?
Researchers are testing if a small monitor can detect early signs of anaphylaxis during a peanut allergy test. The study uses 'stopping rules' from previous research to see if they can safely stop the test before symptoms appear.
What are the potential side effects?
There may not be direct side effects from the monitoring device itself, but participants could experience allergic reactions during the food challenge, which might include itching, swelling, breathing difficulties or full-blown anaphylaxis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4-6 hours (day 1 during the food challenge)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4-6 hours (day 1 during the food challenge) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anaphylaxis occurrence rates in each group
Secondary study objectives
Anaphylaxis likelihood in each group based on the Brighton score
Anaphylaxis severity in each group
Reaction rates in each group

Side effects data

From 2022 Phase 4 trial • 58 Patients • NCT04290624
4%
Headache
4%
Burn oral cavity
4%
Lower respiratory tract infection
4%
COVID-19
4%
Hypercholesterolemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intervention Group
Non-intervention Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Monitor (TEWL) and stopping rulesExperimental Treatment1 Intervention
Wears the monitor, and the food challenge will be done using the new stopping rules to end the test.
Group II: Monitor (TWLG) without stopping rulesActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,833 Previous Clinical Trials
6,423,088 Total Patients Enrolled
2 Trials studying Food Allergy
258 Patients Enrolled for Food Allergy
The Gerber FoundationOTHER
42 Previous Clinical Trials
6,042 Total Patients Enrolled
Chase Schuler, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Food Allergy
200 Patients Enrolled for Food Allergy

Media Library

Monitor (TEWL) without stopping rules (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05696236 — N/A
Food Allergy Research Study Groups: Monitor (TEWL) and stopping rules, Monitor (TWLG) without stopping rules
Food Allergy Clinical Trial 2023: Monitor (TEWL) without stopping rules Highlights & Side Effects. Trial Name: NCT05696236 — N/A
Monitor (TEWL) without stopping rules (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05696236 — N/A
~26 spots leftby Mar 2027
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