Immunologic Basis of Food Protein-Induced Enterocolitis Syndrome

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 60
Healthy Volunteers: f
View:

• Provision of appropriate consent and/or assent

• Age 1-60 years

• Suspected or confirmed FPIES diagnosis

• Reported convincing FPIES reaction (per criteria in 2017 FPIES guidelines) within: (Children \<18 years of age: The past 6-36 months) (Adults age \>18 years: The past 6 months-10 years)

• Individuals of childbearing potential practicing sexual abstinence or using effective methods of contraception during study participation

• English-speaking

Locations
United States
New York
Jaffe Food Allergy Institute at Mount Sinai
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Anna Nowak-Wegrzyn, MD, PhD
Anna.Nowak-wegrzyn@nyulangone.org
212-263-5940
Backup
Joseline Cruz Vazquez, MPH
Joseline.CruzVazquez@nyulangone.org
347-213-8701
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2028-01
Participants
Target number of participants: 72
Treatments
Experimental: Cohort 1
Participants will be sequentially enrolled into 3 cohorts of 24 each.~The first cohort will undergo Low Dose OFC to 300 mg food protein. Following interim analysis of Low Dose OFC outcomes in cohort 1, the Low Dose OFC serving size may be amended or continued at 300 mg food protein for cohort 2 \& 3 based on pre-specified criteria.
Experimental: Cohort 2
Participants will be sequentially enrolled into 3 cohorts of 24 each.~Following interim analysis of Low Dose OFC outcomes in cohort 1, Low-Dose OFC may be continued at 300 mg food protein or be amended for cohort 2 and 3 based on pre-specified criteria.
Experimental: Cohort 3
Participants will be sequentially enrolled into 3 cohorts of 24 each.~Following interim analysis of Low Dose OFC outcomes in cohort 1, Low-Dose OFC may be continued at 300 mg food protein or be amended for cohort 2 and 3 based on pre-specified criteria.
Related Therapeutic Areas
Viral Gastroenteritis
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov

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