RECRUITING

Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome

Conditions

Food Protein-Induced Enterocolitis Syndrome Allergy FPIES Food Diagnosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome

Quick Facts

Study Start:2025-02-24

Study Completion:2028-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06683521

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Anna Nowak-Wegrzyn, MD, PhD

CONTACT

212-263-5940

Anna.Nowak-wegrzyn@nyulangone.org

Joseline Cruz Vazquez, MPH

CONTACT

347-213-8701

Joseline.CruzVazquez@nyulangone.org

Principal Investigator

Anna Nowak-Wegrzyn, MD, PhD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Jaffe Food Allergy Institute at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Anna Nowak-Wegrzyn, MD, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-24

Study Completion Date2028-01

Study Record Updates

Study Start Date2025-02-24

Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

Allergy
FPIES
Food protein-induced enterocolitis syndrome
Food
Diagnosis

Additional Relevant MeSH Terms

Food Protein-Induced Enterocolitis Syndrome