Finding the best way to diagnose food protein-induced enterocolitis syndrome

Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome

This study is testing a new way to diagnose food protein-induced enterocolitis syndrome (FPIES) in people aged 1-60 by giving them small amounts of food to see how they react.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 1 Year to 60 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Drugs / interventions: Chemotherapy, immunotherapy
• Locations: 2 sites (New York, New York and 1 other locations)
• Trial ID: NCT06683521 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the optimal dosing for a novel low-dose, multi-day oral food challenge protocol to diagnose food protein-induced enterocolitis syndrome (FPIES). Participants aged 1-60 years with suspected or confirmed FPIES will undergo a supervised low-dose oral food challenge followed by a home challenge over several days. Those who react will be classified as low-threshold reactors, while those who do not will proceed to a high-dose challenge to assess their tolerance. The study will collect biospecimens from participants who experience symptoms during the challenges to further understand FPIES.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 1-60 years with a suspected or confirmed diagnosis of FPIES.

Not a fit: Patients with a history of severe FPIES requiring hospitalization or those with active gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods for FPIES, allowing for better management and treatment of affected individuals.

How similar studies have performed: While this approach is novel, similar studies have shown promise in improving diagnostic protocols for food allergies.

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

Where this trial is running

New York, New York and 1 other locations

• NYU Langone Health — New York, New York, United States (RECRUITING)
• Jaffe Food Allergy Institute at Mount Sinai — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Anna Nowak-Wegrzyn, MD, PhD — NYU Langone Health
• Study coordinator: Anna Nowak-Wegrzyn, MD, PhD

Conditions: Food Protein-Induced Enterocolitis Syndrome, Allergy, FPIES, Food protein-induced enterocolitis syndrome, Food, Diagnosis