Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
Public ClinicalTrials.gov record NCT06683521. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06683521
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 72 participants
Conditions and interventions
Conditions
Interventions
- 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
Other
Eligibility (public fields only)
- Age range
- 1 Year to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 24, 2025 (Actual)
- Primary completion
- Dec 2027 (Estimated)
- Completion
- Jan 2028 (Estimated)
- Last update posted
- Jun 1, 2026
2025 – 2028
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | Recruiting |
| Jaffe Food Allergy Institute at Mount Sinai | New York | New York | 10029 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06683521, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 1, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06683521 live on ClinicalTrials.gov.