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Behavioural Intervention

TEWL Monitoring for Peanut Allergy Anaphylaxis Prevention (PrePARE Trial)

N/A

Waitlist Available

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 4-6 hours (day 1 during the food challenge)

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transepidermal water loss (TEWL) monitor and stopping rules

2023

N/A

~60

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