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

Pediatric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04644783
• Other study ID #: HUM00156027
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergies
• Enterocolitis
• Food Protein-Induced Enterocolitis Syndrome
• Pediatric Disorder
• Syndrome

Intervention

Diagnostic Test:
• Blood test assay
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 10 weeks (from first food trial)
Secondary	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.	Up to 10 weeks (from first food trial)