An interventional study of Supervised Low-Dose Oral Food Challenge (OFC) and At-Home Low-Dose Oral Food Challenge (OFC) in Food Protein-Induced Enterocolitis Syndrome, sponsored by NYU Langone Health. Recruiting at 2 sites in United States. Open to participants aged 1 Year to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Diagnostic
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.
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 develop, participants will be advised to contact the study team before consuming any further doses.
Participants will return for Visit 2 on Day 8. Those who reported symptoms that led to discontinuation of the home challenge will undergo biospecimen collection. Those who tolerated the Day 1 supervised and Days 2-7 home challenges will undergo a High Dose OFC to their suspected FPIES trigger. Those who tolerate this challenge will be considered to have outgrown their FPIES and instructed to introduce the food regularly at home. Those who react will be considered high-threshold reactors and advised to continue strict avoidance of their FPIES trigger and continue routine allergy care.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be sequentially enrolled into 3 cohorts of 24 each. The first cohort will undergo Low Dose OFC to 300 mg food protein. Following interim analysis of Low Dose OFC outcomes in cohort 1, the Low Dose OFC serving size may be amended or continued at 300 mg food protein for cohort 2 \& 3 based on pre-specified criteria.
Other: Supervised Low-Dose Oral Food Challenge (OFC) · Other: At-Home Low-Dose Oral Food Challenge (OFC) · Other: Supervised High-Dose Oral Food Challenge (OFC)
Participants will be sequentially enrolled into 3 cohorts of 24 each. Following interim analysis of Low Dose OFC outcomes in cohort 1, Low-Dose OFC may be continued at 300 mg food protein or be amended for cohort 2 and 3 based on pre-specified criteria.
Other: Supervised Low-Dose Oral Food Challenge (OFC) · Other: At-Home Low-Dose Oral Food Challenge (OFC) · Other: Supervised High-Dose Oral Food Challenge (OFC)
Participants will be sequentially enrolled into 3 cohorts of 24 each. Following interim analysis of Low Dose OFC outcomes in cohort 1, Low-Dose OFC may be continued at 300 mg food protein or be amended for cohort 2 and 3 based on pre-specified criteria.
Other: Supervised Low-Dose Oral Food Challenge (OFC) · Other: At-Home Low-Dose Oral Food Challenge (OFC) · Other: Supervised High-Dose Oral Food Challenge (OFC)
All participants will undergo a supervised Low Dose OFC (300 mg food protein or amended) on Day 1.
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.
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.
The proportion of individuals with active FPIES who develop FPIES symptoms during the optimal Low Dose multi-day OFC (Days 1-7)
Time frame: Up to Day 7
Percentage of participants who meet criteria for intravenous fluid (IVF) resuscitation among those who develop FPIES symptoms during Low Dose multi-day OFC (Days 1-7)[Time Frame: Up to Day 7]
Time frame: Up to Day 7
Percentage of participants treated with oral ondansetron among those who develop FPIES symptoms during Low Dose multi-day OFC
Time frame: Up to Day 7
Percentage of participants treated with parenteral ondansetron among those who develop FPIES symptoms during Low Dose multi-day OFC
Time frame: Up to Day 7
Percentage of participants with hypotension among those who develop FPIES symptoms during Low Dose multi-day OFC (Days 1-7)
Hypotension defined as: a systolic blood pressure (mmHg): age 1-10: Systolic \<70+(age in years x 2); 11 years or older: \<90 mmHg.
Time frame: Up to Day 7
Percentage of participants with reactions treated in the Emergency Department (ED) among those who develop FPIES symptoms during Low Dose multi-day OFC (Days 1-7)
Time frame: Up to Day 7
Number of participants with reactions resulting in overnight admission to ED/Hospital among those who develop FPIES symptoms during Low Dose multi-day OFC (Days 1-7)
Time frame: Up to Day 7
Median number of emesis episodes among those who develop FPIES symptoms during Low Dose multi-day OFC (Days 1-7)
Time frame: Up to Day 7
Median maximum severity of abdominal pain score (assessed with the FPIES-SS) among those who develop FPIES symptoms during Low Dose multi-day OFC (Days 1-7)
The FPIES-SS is a 15-item questionnaire assessing gastrointestinal symptoms. Each item is rated on a scale from 0-10. The scores corresponding to responses to each question are averaged over the number of days the symptoms were recorded; the final score is calculated by adding averages and dividing by 15 (the number of scorable items). The final score ranges from 0-10; higher scores indicate greater severity of gastrointestinal symptoms.
Time frame: Up to Day 7
Median time to discharge during Day 1 Supervised Low Dose OFC among those who develop FPIES symptoms during Low Dose multi-day OFC
Measure taken on Day 1.
Time frame: Day 1
Median time to resolution of symptoms during Day 1 Supervised Low Dose OFC among those who develop FPIES symptoms during Low Dose multi-day OFC
Measure taken on Day 1.
Time frame: Day 1
Plan to share: Yes — At time of publication, the study team will share primary data (flow cytometry and sequence data) through the National Institute of Allergy and Infectious Diseases (NIAID)-supported repository: "ImmPort." Datasets will be made available immediately after the primary manuscripts from the research have been accepted for publication, with no end date. Upon reasonable request, the investigator who proposed to use the data will be able to access via ImmPort. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
Time frame: No end date.
Access criteria: Upon reasonable request, the investigator who proposed to use the data will be able to access via ImmPort.
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