NCT04644783

Novel Blood Test to Predict Safe Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 1 Month – 7 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will complete surveys and have blood draws during the study. Additionally, participants will be asked to keep track of their diet as well as introduce safe foods identified by the researchers.

Conditions

• Food Protein-Induced Enterocolitis Syndrome
• Allergies
• Pediatric Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood test assay	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.

Timeline

• Start date: 2019-10-08
• Primary completion: 2022-03-22
• Completion: 2022-03-22
• First posted: 2020-11-25
• Last updated: 2024-05-16
• Results posted: 2024-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study