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

NCT04644783 | Completed Results FDA Device

• 1 other identifier: HUM00156027
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Food Protein-Induced Enterocolitis Syndrome; Allergies; Pediatric Disorder

Keywords

Safe foods; Trigger foods; Vomiting

Outcome Measures

Primary Outcomes (1)

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

  A Receiver operating characteristic (ROC) curve was built to estimate the NPV. A random-effects logit model was used to model the binary outcome (safe or trigger food) as a function of the 9 biomarker measurements in the assay. (Expression Value = Relative fold change of 9-gene expression panel in response to food treatment, divided by fold change in response to LPS treatment, multiplied by 1000). The random effect in the logit model took into consideration the correlated data measured within the same subject. A cluster ROC curve analysis was used to assess the precision of the assay. Specifically, the area was computed under the cluster ROC curve (AUC). A threshold to obtain the NPV was selected based on inspection of the ROC curve. At the initial visit, participants had their blood drawn, which was assayed. On average, participants came in up to 4 weeks later after the test results were ready. Participants were then asked to trial a new food each week for up to 7 weeks.

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

Secondary Outcomes (1)

• Positive Predictive Value (PPV), Defined as the Percentage of Test-predicted Unsafe Foods That Are Actually Unsafe Foods.

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

Study Arms (1)

Blood test with assays

EXPERIMENTAL

10 participants with FPIES exhibiting reactions to more than 2 foods will be recruited.

Diagnostic Test: Blood test assay

Interventions

Blood test assay DIAGNOSTIC_TEST

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.

Blood test with assays

Eligibility Criteria

• Age: 1 Month - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Sanders GM, Hua A, Hudson E, Troost JP, Kamada N, Kao JY, Schuler CF 4th, El-Zaatari M. Association of myeloid cell reactivity patterns with safe food predictions in FPIES patients. Allergy Asthma Clin Immunol. 2025 May 21;21(1):24. doi: 10.1186/s13223-025-00968-1.

  PMID: 40400028 DERIVED

MeSH Terms

Conditions

Hypersensitivity; Vomiting

Condition Hierarchy (Ancestors)

Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mohamad El Zaatari
• Organization: University of Michigan

mohamade@med.umich.edu

734-647-2954

Study Officials

• Mohamad El Zaatari, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: October 8, 2019
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)