CompletedNot Applicable

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

United States10 participantsStarted 2019-10-08

Plain-language 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.

Who can participate

Age range1 Month – 7 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Negative Predictive Value (NPV), Defined as the Percentage of Test-predicted Safe Foods That Are Actually Safe Foods.

Timeframe: Up to 7 weeks from the first blood trial, on average 11 weeks

Trial details

NCT IDNCT04644783

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-22

Results submitted2024-02-28

View on ClinicalTrials.gov More Food Protein-Induced Enterocolitis Syndrome trials