Food Protein-Induced Enterocolitis SyndromeINFINITYNCT06683521
Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
A study testing Supervised Low-Dose Oral Food Challenge (OFC), At-Home Low-Dose Oral Food Challenge (OFC) and Supervised High-Dose Oral Food Challenge (OFC) in people with Food Protein-Induced Enterocolitis Syndrome, run by NYU Langone Health at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 1 year to 60 years
- Conditions the study is for
- Food Protein-Induced Enterocolitis Syndrome
- What is being tested?
- Supervised Low-Dose Oral Food Challenge (OFC), At-Home Low-Dose Oral Food Challenge (OFC) and Supervised High-Dose Oral Food Challenge (OFC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Feb 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Anna Nowak-Wegrzyn, MD, PhD
- Recruiting
Jaffe Food Allergy Institute at Mount Sinai
New York, New York, 10029
Mary Grace Baker, MD, MS
About this study
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.
Read the detailed 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 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.
- Being tested
- Supervised Low-Dose Oral Food Challenge (OFC), At-Home Low-Dose Oral Food Challenge (OFC), Supervised High-Dose Oral Food Challenge (OFC)
- Keywords
- Allergy, FPIES, Food protein-induced enterocolitis syndrome, Food, Diagnosis
- Medical subject headings
- Hypersensitivity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Low-Dose Oral Food Challenge (OFC)Other
All participants will undergo a supervised Low Dose OFC (300 mg food protein or amended) on Day 1.
At-Home Low-Dose Oral Food Challenge (OFC)Other
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.
Supervised High-Dose Oral Food Challenge (OFC)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: 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) |
| Cohort 2 | Experimental | 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. Receives: 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) |
| Cohort 3 | Experimental | 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of individuals with active FPIES who develop FPIES symptoms during the optimal Low Dose multi-day OFC (Days 1-7)
Measured: Up to Day 7
Secondary outcomes (10)
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]
Measured: Up to Day 7
Percentage of participants treated with oral ondansetron among those who develop FPIES symptoms during Low Dose multi-day OFC
Measured: Up to Day 7
Percentage of participants treated with parenteral ondansetron among those who develop FPIES symptoms during Low Dose multi-day OFC
Measured: 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.
Measured: 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)
Measured: 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)
Measured: Up to Day 7
Median number of emesis episodes among those who develop FPIES symptoms during Low Dose multi-day OFC (Days 1-7)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start24 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Protein-Induced Enterocolitis SyndromeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Nowak-Wegrzyn, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683521
- Sponsor's protocol ID
- 23-01346
- Other IDs
- U01AI170836-01
- Acronym
- INFINITY
- Status last verified
- May 2026
- First submitted
- 8 Nov 2024
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
- ClinicalTrials.gov ID
- NCT06683521
- Acronym / sponsor ID
- INFINITY / 23-01346
- Keywords
- Allergy, FPIES, Food protein-induced enterocolitis syndrome, Food, Diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | 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. 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. |
| Cohort 2 | Experimental | 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. |
| Cohort 3 | Experimental | 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. |
Who may qualify
- Ages
- 1 year to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised Low-Dose Oral Food Challenge (OFC)All participants will undergo a supervised Low Dose OFC (300 mg food protein or amended) on Day 1. | Other | Cohort 1, Cohort 2, Cohort 3 |
| At-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. | Other | Cohort 1, Cohort 2, Cohort 3 |
| Supervised 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. | Other | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
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
10 secondary outcomes
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)
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)
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
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
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Nowak-Wegrzyn, MD, PhD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Low-Dose Oral Food Challenge (OFC), At-Home Low-Dose Oral Food Challenge (OFC) and Supervised High-Dose Oral Food Challenge (OFC) in people with Food Protein-Induced Enterocolitis Syndrome, run by NYU Langone Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Nowak-Wegrzyn, MD, PhD (212-263-5940, Anna.Nowak-wegrzyn@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.