NCT06683521 Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
| NCT ID | NCT06683521 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Food Protein-Induced Enterocolitis Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2025-02-24 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 72 participants in total. It began in 2025-02-24 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Anna Nowak-Wegrzyn, MD, PhD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06683521 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 60 Years, studying Food Protein-Induced Enterocolitis Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06683521 currently recruiting?
Yes, NCT06683521 is actively recruiting participants. Contact the research team at Anna.Nowak-wegrzyn@nyulangone.org for enrollment information.
Where is the NCT06683521 trial being conducted?
This trial is being conducted at New York, United States, New York, United States.
Who is sponsoring the NCT06683521 clinical trial?
NCT06683521 is sponsored by NYU Langone Health. The principal investigator is Anna Nowak-Wegrzyn, MD, PhD at NYU Langone Health. The trial plans to enroll 72 participants.