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Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
NCT06683521 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- 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)
Study Locations (2)
New York
- NYU Langone Health — New York
- Jaffe Food Allergy Institute at Mount Sinai — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2028-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06683521
The ClinicalTrials.gov registry entry for NCT06683521 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Food Protein-Induced Enterocolitis Syndrome appearing as the primary indexed condition, and to 3 interventions — of which Supervised Low-Dose Oral Food Challenge (OFC) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06683521 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06683521 about?
NCT06683521 is a clinical study titled "Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome". 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...
What is the current status of trial NCT06683521?
This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2025-02-24. Estimated completion is 2028-01.
What conditions does trial NCT06683521 study?
This clinical trial studies the following conditions: Food Protein-Induced Enterocolitis Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06683521?
The interventions under investigation include: Supervised Low-Dose Oral Food Challenge (OFC) (OTHER), At-Home Low-Dose Oral Food Challenge (OFC) (OTHER), Supervised High-Dose Oral Food Challenge (OFC) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06683521?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06683521 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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