Oral Immunotherapy for Food Protein Induced Enterocolitis Syndrome

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called oral immunotherapy (OIT) for children with a food allergy known as Food Protein Induced Enterocolitis Syndrome (FPIES). FPIES can cause severe reactions, like vomiting and fatigue, after eating certain foods. Currently, the main way to manage FPIES is to avoid those foods, but some children don't outgrow the allergy. This trial aims to see if OIT can help these children develop a tolerance to foods that usually cause them problems. The study will compare children receiving OIT with those continuing on the elimination diet to see which method is more effective and safe.

To be eligible for this trial, children must be under 18 years old and have experienced an acute episode of FPIES within the last month. The trial will enroll participants from various locations and will involve monitoring how well each treatment works and any side effects that occur. If you have a child who fits these criteria and has persistent FPIES, this trial could offer a new approach to help them manage their allergy. Participants will receive support and guidance throughout the study to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• • Pediatric patients (under 18 years of age) affected by persistent acute food protein-induced enterocolitis syndrome.
• • The last anamnestic acute episode must not be more than 1 month prior to the date of inclusion in the study. The anamnestic definition of acute episode will be based on the use of Miceli Sopo 2022 questionnaire for food protein-induced enterocolitis syndrome. In case it is not clear whether the disease is active or not, an oral food challenge will be performed to verify the possible acquisition of tolerance (a procedure that is part of the routine management for this allergy). Inclusion in the study must occur within 1 month of the possible failure of the aforementioned oral food challenge. Regarding patients with multiple FPIES (expected to be approximately 6% of the total patients included, a small minority), OIT will be started for the nutritionally most relevant food among those eligible.
• • Exclusion criteria
• • Absence of inclusion criteria.
• • Transition from acute FPIES to IgE-mediated AA.
• • Absence of informed consent approval by their caregivers.
• • Failure to use email by their caregivers.