NCT06683521 · NYU Langone Health
Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
(INFINITY)
What this study is about
This is a phase I conducted at multiple hospitals clinical trial that aims to find the optimal dose for conducting a novel low-dose, multi-day taken by mouth 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.
View original scientific description
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.
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations