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

University of Michigan

Status

Completed

Conditions

Pediatric Disorder

Food Protein-Induced Enterocolitis Syndrome

Allergies

Treatments

Diagnostic Test: Blood test assay

Study type

Interventional

Funder types

Other

Identifiers

NCT04644783

HUM00156027

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

1 month to 7 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of FPIES
Have to have documented reactions to 2-3 trigger foods with recurrent delayed vomiting or documented reactions to 4 or more trigger foods with recurrent delayed vomiting.

Exclusion criteria

Patients who are currently on medications that suppress the immune system
Patients who do not have at least 2 trigger foods identified.
Patients who have a history of an organic Gastrointestinal (GI) disease (e.g., inflammatory bowel disease, celiac disease, biliary disorders, bowel resection), cardiac, pulmonary, neurologic, renal, endocrine, or gynecological pathology
Lack of parental or guardian informed consent.