Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06683521
Status
Recruiting
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Conditions

  • Food Protein-Induced Enterocolitis Syndrome

Eligibility Criteria

Sex
ALL
Age
1 Year - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Supervised Low-Dose Oral Food Challenge (OFC) — OTHER
    All participants will undergo a supervised Low Dose OFC (300 mg food protein or amended) on Day 1.
  • At-Home Low-Dose Oral Food Challenge (OFC) — OTHER
    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.
  • Supervised High-Dose Oral Food Challenge (OFC) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cohort 1
    Participants will be sequentially enrolled into 3 cohorts of 24 each. The first cohort will undergo Low Dose OFC to 300 mg food protein. Following interim analysis of Low Dose OFC outcomes in cohort 1, the Low Dose OFC serving size may be amended or continued at 300 mg food protein for cohort 2 \& 3 based on pre-specified criteria.
  • Experimental: Cohort 2
    Participants will be sequentially enrolled into 3 cohorts of 24 each. Following interim analysis of Low Dose OFC outcomes in cohort 1, Low-Dose OFC may be continued at 300 mg food protein or be amended for cohort 2 and 3 based on pre-specified criteria.
  • Experimental: Cohort 3
    Participants will be sequentially enrolled into 3 cohorts of 24 each. Following interim analysis of Low Dose OFC outcomes in cohort 1, Low-Dose OFC may be continued at 300 mg food protein or be amended for cohort 2 and 3 based on pre-specified criteria.

Primary Outcome Measure

The proportion of individuals with active FPIES who develop FPIES symptoms during the optimal Low Dose multi-day OFC (Days 1-7) [ Time Frame: Up to Day 7 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Jaffe Food Allergy Institute at Mount SinaiNew YorkNew York10029
Mary Grace Baker, MD, MS (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Anna Nowak-Wegrzyn, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Jaffe Food Allergy Institute at Mount Sinai· New York, NYNYU Langone Health· New York, NY