New Low-Dose food challenge could make FPIES diagnosis safer

NCT ID NCT06683521

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new, low-dose food challenge given over several days to diagnose FPIES, a food allergy that causes vomiting and diarrhea. Researchers want to find the safest dose that can still trigger symptoms in people with FPIES. The study involves 72 people aged 1 to 60 with suspected or confirmed FPIES. Participants will eat small amounts of the trigger food under supervision and at home, with a higher dose challenge at the end if tolerated.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

What this could lead to
If successful, this could lead to a safer, more accurate way to diagnose FPIES, reducing the need for high-dose food challenges that can cause severe reactions.
What could go wrong
This is an early-phase study with only 72 participants, so results may not apply to everyone. The low-dose challenge might still trigger symptoms, and the protocol may not be widely adopted without further testing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for FOOD PROTEIN-INDUCED ENTEROCOLITIS SYNDROME are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Study contacts

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

  • Contact

    Phone: •••-•••-•••• Email: •••••@•••••

Locations

  • Jaffe Food Allergy Institute at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

    Contact

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

    Contact