Oral Immunotherapy for Food Protein Induced Enterocolitis Syndrome

NANot yet recruitingINTERVENTIONAL
Enrollment

168

Participants

Timeline

Start Date

October 1, 2024

Primary Completion Date

October 1, 2027

Study Completion Date

March 31, 2028

Conditions
FPIES
Interventions
PROCEDURE

Oral immunotherapy (OIT)

OIT in DOPA group will be implemented as follows. Both the first micro-dose of the offending food and the subsequent micro-increments will be administered at home. Any interruptions and resumptions of OIT, due to intercurrent events (e.g. infections), will be managed via email with or without medical visit via video call. Patients will be provided with ondansetron (sublingual film) and instructions for its use. An explanatory letter will also be provided in case of need for emergency room access.

DIETARY_SUPPLEMENT

Culprit food elimination diet

The Diet group consists of a population of children affected by acute persistent FPIES subjected to the traditional measure, i.e. the elimination diet of the incriminated food.

Trial Locations (1)

00168

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Pediatria, Roma

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

NCT06614244 - Oral Immunotherapy for Food Protein Induced Enterocolitis Syndrome | Biotech Hunter | Biotech Hunter