Actively Recruiting
Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
Led by NYU Langone Health · Updated on 2026-05-08
72
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide appropriate consent and/or assent
- Be between 1 and 60 years old
- Have a suspected or confirmed diagnosis of FPIES
- Have had a convincing FPIES reaction within the past 6-36 months if under 18 years old, or within the past 6 months to 10 years if 18 years or older
- Individuals of childbearing potential must practice sexual abstinence or use effective contraception during the study
- Be able to speak English
You will not qualify if you...
- History of severe FPIES involving hospitalization with neurological issues or life support
- Acute FPIES reaction in the past 6 months
- Frequent gastrointestinal symptoms like nausea, abdominal pain, reflux, heartburn, vomiting, diarrhea, or constipation
- Active eosinophilic gastrointestinal disorders, inflammatory bowel disease, gastroesophageal reflux disease, or other chronic gastrointestinal conditions
- Poorly controlled atopic dermatitis at screening
- Poorly controlled or severe asthma or wheezing at screening, including recent corticosteroid use or hospitalization
- IgE-mediated food allergies without identified trigger
- Inability to stop prohibited medications for 7 days before screening and during participation except rescue medications
- Personal or family history of prolonged QT syndrome
- Personal history of arrhythmia
- Current arterial hypertension, cardiovascular disease, chronic autoimmune disease, or liver disease
- Primary or secondary immunodeficiency
- Phenylketonuria (due to certain medication contents)
- Use of systemic steroids within 30 days before screening
- Chemotherapy, radiotherapy, or systemic immunosuppressive drugs within past 12 months
- Use of biologic drugs or allergen-specific immunotherapy within past 12 months
- Inability to delay routine immunizations or immune globulin during study
- Allergy to ondansetron, dolasetron, granisetron, or palonosetron
- Pregnancy or breastfeeding
- Any other medical condition or findings that may increase risks or affect study participation or data quality as judged by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
Jaffe Food Allergy Institute at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
A
Anna Nowak-Wegrzyn, MD, PhD
CONTACT
J
Joseline Cruz Vazquez, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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