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 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.

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Key information

Conditions

Food Protein-Induced Enterocolitis Syndrome Allergies Hypersensitivity Immune System Diseases Pathological Conditions, Signs and Symptoms Pediatric Disorder Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

1 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

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.

Secondary outcomes

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

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

The same ROC curve described for the primary outcome was used to derive the PPV. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Nov 25, 2020
Registry last updated: May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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