NCT06683521View on ClinicalTrials.gov

Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome

NARecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

February 24, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

January 31, 2028

Conditions
Food Protein-Induced Enterocolitis Syndrome
Interventions
OTHER

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

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

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.

Trial Locations (2)

10016

RECRUITING

NYU Langone Health, New York

10029

RECRUITING

Jaffe Food Allergy Institute at Mount Sinai, New York

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

NYU Langone Health

OTHER