New York, NYNCT06683521Now EnrollingIRB Ready

Food Protein-Induced Enterocolitis Syndrome Clinical Trial in New York, NY

Access cutting-edge food protein-induced enterocolitis syndrome treatment through this clinical trial at a research site in New York. Study-provided care at no cost to qualified participants.

Sponsored by NYU Langone Health

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Expert Care in New York

Access food protein-induced enterocolitis syndrome specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related food protein-induced enterocolitis syndrome treatment provided free

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Check if you qualify for this food protein-induced enterocolitis syndrome clinical trial in New York, NY

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Why Participate?

  • No-Cost Study Care

  • Local to New York

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New York site if eligible
  4. 4Begin participation

About This Food Protein-Induced Enterocolitis Syndrome Study in New York

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.

Sponsor: NYU Langone Health

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New York?

Yes, this clinical trial (NCT06683521) has an active research site in New York, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Food Protein-Induced Enterocolitis Syndrome Treatment Options in New York, NY

If you're searching for food protein-induced enterocolitis syndrome treatment options in New York, NY, this clinical trial (NCT06683521) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New York research site is actively enrolling participants for this clinical trial. You'll receive care from experienced food protein-induced enterocolitis syndrome specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all food protein-induced enterocolitis syndrome clinical trials near you to find additional studies recruiting in your area.

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