← Back to Search

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
Diagnosis of FPIES
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 weeks (from first food trial)
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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with FPIES.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 weeks (from first food trial)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 weeks (from first food trial) 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 proportion of test-predicted safe foods that are actually safe foods.
Secondary outcome measures
Positive predictive value (PPV), defined as the proportion of test-predicted unsafe foods that are actually unsafe foods.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Blood test with assaysExperimental Treatment1 Intervention
Ten patients with FPIES exhibiting reactions to 2-3 foods, and up to 10 exhibiting FPIES reactions to 4 or more foods will be recruited.

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,780 Previous Clinical Trials
6,364,515 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

Frequently Asked Questions

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

Is participation in this research initiative open to me?

"Eligibility for this medical trial requires participants to have hypersensitivity, be between 1 Month and 7 years old, and only about 20 individuals will be accepted."

Answered by AI

Has enrollment opened for this experiment yet?

"Clinicaltrials.gov indicates that this particular medical study is no longer actively recruiting patients since its last update on November 7th 2022. Despite this, the website shows that 1677 other trials are currently looking for volunteers to participate in their research."

Answered by AI

Is geriatric participation allowed in this experiment?

"The lower limit for entry into this study is one month, while the upper age cap stands at seven years old."

Answered by AI
~4 spots leftby Mar 2025