N/A
N=10
Novel Blood Test to Predict Safe Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)
Food Protein-Induced Enterocolitis Syndrome · Allergies · Pediatric Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04644783 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Negative Predictive Value (NPV), Defined as the Percentage of Test-predicted Safe Foods That Are Actually Safe Foods. — 98.5; 73.16 percentage — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Blood test assay (Diagnostic_test)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative Predictive Value (NPV), Defined as the Percentage of Test-predicted Safe Foods That Are Actually Safe Foods. |
98.5; 73.16 | <0.0001 sig |
| SECONDARY Positive Predictive Value (PPV), Defined as the Percentage of Test-predicted Unsafe Foods That Are Actually Unsafe Foods. |
31.1 | <0.0001 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04644783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.