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NCT06683521 · ClinicalTrials.gov registry record · NA
Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome
A NA study of Food Protein-Induced Enterocolitis Syndrome, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 2
- Study locations
NCT06683521 is a NA study of Food Protein-Induced Enterocolitis Syndrome that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 72 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT06683521, a NA study of Food Protein-Induced Enterocolitis Syndrome, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 2
- Study locations
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 |
Interested in This Trial?
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, categorized as NA. 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 1,164 total studies on file at ClinicalTrials.gov.
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.
NCT06683521 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
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.
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).
Who is sponsoring clinical trial NCT06683521?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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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