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

Primary Purpose

Food Protein-Induced Enterocolitis Syndrome, Allergies, Pediatric Disorder

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Blood test assay

About this trial

This is an interventional diagnostic trial for Food Protein-Induced Enterocolitis Syndrome focused on measuring Safe foods, Trigger foods, Vomiting

Eligibility Criteria

1 Month - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood test with assays

Arm Description

Ten patients with FPIES exhibiting reactions to 2-3 foods, and up to 10 exhibiting FPIES reactions to 4 or more foods will be recruited.

Outcomes

Primary Outcome Measures

Negative predictive value (NPV), defined as the proportion of test-predicted safe foods that are actually safe foods.

The study team will build a Receiver operating characteristic (ROC) curve to estimate the NPV. A random-effects logit model will be used to model the binary outcome (safe or trigger food) as a function of the 9 biomarker measurements in the assay. The random effect in the logit model will take into consideration of the correlated data measured within the same subject. A cluster Receiver operating characteristic (ROC) curve analysis will be used to assess the precision of the assay. Specifically, the study team will compute the area under the cluster ROC curve (AUC), along with a 95% confidence interval (CI). The assay is predictive if the lower limit of the 95% CI is above 0.5, which is the null value indicating no predictive ability. Given the assay is predictive, the team will select a threshold to obtain the NPV.

Secondary Outcome Measures

Positive predictive value (PPV), defined as the proportion of test-predicted unsafe foods that are actually unsafe foods.

The study team will use the same ROC curve described for the primary outcome to derive the PPV.

Full Information

NCT ID

NCT04644783

First Posted

November 19, 2020

Last Updated

November 7, 2022

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT04644783

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

October 8, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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 ten participants that will have 2-3 trigger foods as well as ten participants with 4 or more trigger foods.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Food Protein-Induced Enterocolitis Syndrome, Allergies, Pediatric Disorder

Keywords

Safe foods, Trigger foods, Vomiting

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Blood test with assays

Arm Type

Experimental

Arm Description

Ten patients with FPIES exhibiting reactions to 2-3 foods, and up to 10 exhibiting FPIES reactions to 4 or more foods will be recruited.

Intervention Type

Diagnostic Test

Intervention Name(s)

Blood test assay

Intervention Description

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 Outcome Measure Information:

Title

Negative predictive value (NPV), defined as the proportion of test-predicted safe foods that are actually safe foods.

Description

Time Frame

Up to 10 weeks (from first food trial)

Secondary Outcome Measure Information:

Title

Positive predictive value (PPV), defined as the proportion of test-predicted unsafe foods that are actually unsafe foods.

Description

The study team will use the same ROC curve described for the primary outcome to derive the PPV.

Time Frame

Up to 10 weeks (from first food trial)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamad El Zaatari, PhD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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