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COMPLETEDNANCT04644783

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

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 devel...

Lead sponsor: University of Michigan•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Michigan

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.

Age

0 - 7 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 16, 2024Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment10

Start dateOct 2019

Last updatedMay 16, 2024

Condition

Food Protein-Induced Enterocolitis Syndrome Allergies Pediatric Disorder

Locations shown

University of Michigan

Ann Arbor, Michigan

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2024Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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