Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
NYU Langone Health
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.
Description
At the time of enrollment, participants will undergo screening (Visit 0) and complete a baseline gastrointestinal symptom diary. At Visit 1 (Day 1), participants will undergo a supervised Low Dose OFC to their FPIES trigger. Those who react will be considered low-threshold reactors and recommended to continue strict avoidance of their FPIES trigger. For participants who do not react at the Day 1 Low Dose OFC, continued participation involves a daily home challenge on Days 2-7. Participants will be provided with a diary to monitor symptoms. If objective or persistent subjective symptoms devel…
Eligibility
- Age range
- 1–60 years
- Sex
- All
- Healthy volunteers
- No
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 comprom…
Interventions
- OtherSupervised Low-Dose Oral Food Challenge (OFC)
All participants will undergo a supervised Low Dose OFC (300 mg food protein or amended) on Day 1.
- OtherAt-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.
- OtherSupervised 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.
Locations (2)
- NYU Langone HealthNew York, New York
- Jaffe Food Allergy Institute at Mount SinaiNew York, New York