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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

PrePARE Trial 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.Check my eligibility

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.See study design

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.

PrePARE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anaphylaxis occurrence rates in each group

Secondary outcome measures

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

COVID-19

Lower respiratory tract infection

Headache

Burn oral cavity

Hypercholesterolemia

100%

80%

60%

40%

20%

Study treatment Arm

Intervention Group

Non-intervention Group

PrePARE 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,797 Previous Clinical Trials

6,378,018 Total Patients Enrolled

2 Trials studying Food Allergy

258 Patients Enrolled for Food Allergy

The Gerber FoundationOTHER

41 Previous Clinical Trials

5,956 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being accepted for this investigation?

"Clinicaltrials.gov reveals that this particular trial, which was initially advertised on March 1st of 2023 and last updated January 13th of the same year, is no longer recruiting subjects. Nonetheless, there are several other studies actively in need of participants at present time."

Answered by AI

Does this research extend to minors?

"The specifications for admittance into this trial stipulate that potential enrollees must be between 6 months and 5 years old. This medical research has additionally created separate trials specifically tailored to minors and those over the age of 65, respectively constituting 3 tests and 2 studies."

Answered by AI

Does my profile qualify me to join this medical research endeavor?

"This research study is in search of 40 minors aged 6 Months to 5, who have verifiable food allergies as confirmed by an allergist. The participants must also pass the 80% likelihood positive predictive value threshold for peanut allergy based on either their skin or blood immunoglobulin E (IgE) tests and meet all clinical oral food challenge requirements including no asthma exacerbations, recent viral infections, antibiotics use or food reactions within the past 30 days."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Predicting Peanut Anaphylaxis and Reducing Epinephrine

Charles (Chase) Schuler 2023. "Predicting Peanut Anaphylaxis and Reducing Epinephrine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05696236.

All > Food Allergy