Immune causes of FPIES
Immune Basis of FPIES
This project tests whether a low-dose, multi-day food challenge can make diagnosis easier and safer for infants and children with FPIES compared with the standard hospital oral food challenge.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Northwestern University NIH-funded |
| Lab location | 1 site (Chicago, United States) |
| Project ID | NIH-11128362 on NIH RePORTER |
What this research studies
You may be randomly assigned to the usual hospital oral food challenge or to a new low-dose approach that starts with a 300 mg protein challenge in the hospital and continues with daily 300 mg doses at home for seven days while symptoms are tracked. The study uses a 1:2 randomization so more participants try the low-dose multi-day protocol. Researchers will collect symptom data and blood samples to look for immune markers that explain why FPIES happens. The goal is to find less traumatic diagnostic methods and better biological signs of the condition.
Who could benefit from this research
Good fit: Infants and children with a history of FPIES or those scheduled for an oral food challenge to determine if FPIES is still active are the ideal candidates.
Not a fit: People without FPIES, those with IgE-mediated food allergy, or those unable to travel to the study site or carry out safe home dosing are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could reduce the need for high-risk hospital challenges, make testing less traumatic, and point toward blood tests that help diagnose FPIES.
How similar studies have performed: Single-day hospital oral food challenges are the established standard, while low-dose multi-day home challenge approaches are relatively new and have limited prior testing.
Where this research is happening
Chicago, United States
- Northwestern University — Chicago, United States (Active)
Researchers
- Principal investigator: Berin, Cecilia — Northwestern University
- Study coordinator: Berin, Cecilia
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.