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Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome

NCT06683521 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-05-08

No results posted yet for this study

Summary

This is a phase I multicenter clinical trial that aims to find the optimal dose for conducting a novel low-dose, multi-day oral food challenge (OFC) protocol for diagnosing food protein-induced enterocolitis syndrome (FPIES). Individuals ages 1-60 years with a history of suspected or confirmed FPIES will be eligible for enrollment. Recruitment is expected to occur over 3 years.

Conditions

  • Food Protein-Induced Enterocolitis Syndrome

Interventions

OTHER

Supervised Low-Dose Oral Food Challenge (OFC)

All participants will undergo a supervised Low Dose OFC (300 mg food protein or amended) on Day 1.

OTHER

At-Home Low-Dose Oral Food Challenge (OFC)

Participants who tolerate the Day 1 Low Dose OFC will undergo a daily Low-Dose OFC (300 mg food protein or amended) at home on Days 2-7.

OTHER

Supervised High-Dose Oral Food Challenge (OFC)

Participants who tolerate the Days 1-7 Low Dose OFC will undergo a supervised High Dose OFC (maximum 3000 mg food protein) on Day 8.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Anna Nowak-Wegrzyn, MD, PhD · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-04
Primary Completion
2027-12-31
Completion
2028-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06683521 on ClinicalTrials.gov