168
Participants
Start Date
October 1, 2024
Primary Completion Date
October 1, 2027
Study Completion Date
March 31, 2028
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.
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.
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Pediatria, Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER