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Diagnostic Test

Blood Test Assay for FPIES

N/A
Waitlist Available
Led By Mohamad El Zaatari, PhD
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 up to 7 weeks from the first blood trial, on average 11 weeks
Awards & highlights

Study Summary

This trial is testing a new blood assay to see if it can identify safe foods for people with food protein-induced enterocolitis syndrome (FPIES).

Eligible Conditions
  • Food Protein-Induced Enterocolitis Syndrome
  • Allergy
  • Pediatric Disorders

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 weeks from the first blood trial, on average 11 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 weeks from the first blood trial, on average 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Negative Predictive Value (NPV), Defined as the Percentage of Test-predicted Safe Foods That Are Actually Safe Foods.
Secondary outcome measures
Positive Predictive Value (PPV), Defined as the Percentage of Test-predicted Unsafe Foods That Are Actually Unsafe Foods.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Blood test with assaysExperimental Treatment1 Intervention
10 participants with FPIES exhibiting reactions to more than 2 foods will be recruited.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood test assay
2019
N/A
~10

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,810 Previous Clinical Trials
6,385,095 Total Patients Enrolled
Mohamad El Zaatari, PhDPrincipal InvestigatorUniversity of Michigan

Media Library

Novel Blood Test (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT04644783 — N/A
Food Enterocolitis Syndrome Research Study Groups: Blood test with assays
Food Enterocolitis Syndrome Clinical Trial 2023: Novel Blood Test Highlights & Side Effects. Trial Name: NCT04644783 — N/A
Novel Blood Test (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04644783 — N/A
~2 spots leftby Jun 2025
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