Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04644783 · ClinicalTrials.gov registry record · NA
Novel Blood Test to Predict Safe Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)
A NA study of Allergies and Pediatric Disorder, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT04644783: Completed NA study of Allergies and Pediatric Disorder, sponsored by University of Michigan.
NCT04644783 is a NA study of Allergies and Pediatric Disorder that has completed, run by University of Michigan. The registered enrollment target is 10 participants, below the 3,473-participant average among 6 other Allergies trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04644783, a NA study of Allergies and Pediatric Disorder, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 th
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Blood test assay
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2022-03-22 |
| Phase | NA |
What the finished NCT04644783 record still lists
NCT04644783 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 3,473-participant average among 6 other Allergies trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Allergies appearing as the primary indexed condition, and to 1 intervention - of which Blood test assay is the first listed.
NCT04644783 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04644783 about?
NCT04644783 is a clinical study titled "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 t...
What is the current status of trial NCT04644783?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2019-10-08. Estimated completion is 2022-03-22.
What conditions does trial NCT04644783 study?
This clinical trial studies the following conditions: Allergies, Pediatric Disorder, Food Protein-Induced Enterocolitis Syndrome.
What interventions are being tested in trial NCT04644783?
The interventions under investigation include: Blood test assay (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04644783?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04644783 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Allergies
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Partners in Children's Health (CSN): A Randomized Trial of an Attachment Based Intervention
RECRUITING · NA
-
Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
RECRUITING · Phase 2
-
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
RECRUITING
-
Omalizumab Weight-Based Dosing Efficacy Trial
RECRUITING · Phase 2
-
Induced Tolerogenic Dendritic Cells as Modulators of Allergic Asthma
COMPLETED · Phase 1
-
T Cell Effector and Regulatory Mechanisms in Asthma
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00623389 · 10 participants · NA
Evaluation of an Advanced Lower Extremity Neuroprostheses
- NCT01241864 · 10 participants · Phase 2
Islet Transplantation in Type 1 Diabetic Kidney Allograft
- NCT01293214 · 10 participants · NA
Vascularized Composite Allotransplantation for Multiple Extremity Amputations
- NCT01474148 · 10 participants · NA
A Neuroprosthesis for Seated Posture and Balance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI