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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: Recruiting NA study of Food Protein-Induced Enterocolitis Syndrome, sponsored by NYU Langone Health.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT06683521 shows while recruiting
NCT06683521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Food Protein-Induced Enterocolitis Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06683521's enrollment target sits among peer trials
72 1090th of 2000 higher than 899 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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