Recruiting

Observational StudyImmunologic Basis of Food Protein-Induced Enterocolitis Syndrome

Sponsor:

NYU Langone Health

Code:

NCT06683521

Conditions

Food Protein-Induced Enterocolitis Syndrome

Eligibility Criteria

Sex: All

Age: 1 - 60

Healthy Volunteers: Not accepted

Interventions

Supervised Low-Dose Oral Food Challenge (OFC)

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

Supervised High-Dose Oral Food Challenge (OFC)

Study Details

Brief 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

Study ID

NCT06683521

Start date

Feb 24, 2025

Status verified date

May, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 1 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

Provision of appropriate consent and/or assent
Age 1-60 years
Suspected or confirmed FPIES diagnosis
Reported convincing FPIES reaction (per criteria in 2017 FPIES guidelines) within: (Children <18 years of age: The past 6-36 months) (Adults age >18 years: The past 6 months-10 years)
Individuals of childbearing potential practicing sexual abstinence or using effective methods of contraception during study participation
English-speaking

Exclusion Criteria:

Past severe FPIES defined as hospitalization due to an acute FPIES reaction with neurological compromise or requiring life support
Acute FPIES reaction in the past 6 months
Frequent gastrointestinal symptoms: nausea, abdominal pain, reflux, heartburn, emesis, diarrhea, constipation per participant or guardian report or as evidenced by FPIES Symptoms Score (FPIES-SS)
Current active eosinophilic gastrointestinal disorders, inflammatory bowel disease, gastroesophageal reflux disease, or any other chronic gastrointestinal condition
Poorly controlled atopic dermatitis at screening per PI discretion
Poorly controlled or severe asthma/wheezing at screening, defined by at least one of the following criteria: 1: History of two or more systemic corticosteroid courses within six months of screening or one course of systemic corticosteroids within three months of screening to treat asthma/wheezing; 2: Prior intubation/mechanical ventilation for asthma/wheezing; 3: One hospitalization or ED visit for asthma/wheezing within six months of screening; and 4: Inhaled corticosteroid (ICS) dosing of >500 mcg daily fluticasone (or equivalent ICS based on National Heart, Lung, and Blood Institute (NHLBI) dosing chart).
IgE-mediated food allergies where the trigger has not been identified
Inability to discontinue prohibited medications for 7 days prior to the screening visit and lasting for the duration of study participation unless indicated for use as rescue medication
Personal or family history of prolonged QT syndrome
Personal history of arrhythmia
Current diagnosis of arterial hypertension
Current diagnosis of cardiovascular disease
Current diagnosis of any chronic autoimmune disease
Current diagnosis of liver disease
Primary or secondary immunodeficiency
Phenylketonuria (PKU) (ondansetron tablets may contain phenylalanine)
Use of systemic steroids within 30 days of screening
Chemotherapy, radiotherapy, or any systemic immunosuppressive drugs in the past 12 months
Use of biologic drugs or allergen-specific immunotherapy by any route in the past 12 months
Inability to defer routine immunizations or passive immunization with immune globulin for the duration of participation in the study
Allergy to any of the following medications: ondansetron (Zofran), dolasetron (Azemet), granisetron (Kytril), or palonosetron (Aloxi)
Pregnancy or breastfeeding
Current or past medical problems or findings from the physical examination or screening evaluation not listed above, which, in the opinion of the investigator(s), may pose additional risks from study participation, interfere with the participant's ability to comply with study requirements, and/or impact the quality or interpretation of the data obtained from the study

Study Design

Enrollment

72 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

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.

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.

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.

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 and Locations

Central contacts

Anna Nowak-Wegrzyn, MD, PhD

212-263-5940 Anna.Nowak-wegrzyn@nyulangone.org

Joseline Cruz Vazquez, MPH

347-213-8701 Joseline.CruzVazquez@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Anna Nowak-Wegrzyn, MD, PhD

Jaffe Food Allergy Institute at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Mary Grace Baker, MD, MS

More Information

Sponsor

NYU Langone Health

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

Allergy
FPIES
Food protein-induced enterocolitis syndrome
Food
Diagnosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-06-01.