CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Blood test assayother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04644783
NCT04644783N/ACompleted
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A Novel Blood Test to Predict Safe (Non-trigger) Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)

University of Michigan·interventional·Posted Nov 25, 2020·Updated May 16, 2024

In Brief

A clinical study evaluating Blood test assay for Food Protein-Induced Enterocolitis Syndrome and 2 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The aim of this study is to validate a blood test that can identify safe foods for food protein-induced enterocolitis syndrome (FPIES). This study proposes a solution to the problems of FPIES by developing a new blood assay that screens a large number of foods (more than 20) in a culture plate. If this blood test is successful it may be able to identify safe foods more quickly. The study will recruit 10 participants that will have more than 2 trigger foods.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFood Protein-Induced Enterocolitis Syndrome, Allergies, Pediatric Disorder
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedNov 25, 2020
Enrollment StartOct 8, 2019
Primary CompletionMar 22, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.6 years ago

Interventions

Blood test assayother

Participants will have their blood drawn and be evaluated with a new blood assay that screens a large number of foods (more than 20) in a culture plate. Participants will be asked to eat the identified safe foods by the the blood assay.