Oral Immunotherapy for Food Protein Induced Enterocolitis Syndrome

Not Applicable

Not yet recruiting

• Conditions: FPIES
• Interventions: Procedure: Oral immunotherapy (OIT); Dietary Supplement: Culprit food elimination diet

• Registration Number: NCT06614244
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

Food Protein Induced Enterocolitis Syndrome (FPIES) is a food allergy characterized by clinical manifestations of varying severity that can be, very rarely, severe to the point of leading to shock. Acute FPIES is nowaday the most common presentation of the disease. It is characterized by repeated, projectile vomiting (usually arising between 1 and 4 hours after ingestion of the culprit food) accompanied by pallor, hypotonia, and lethargy, with complete resolution of the aforementioned symptoms almost always within a few hours. Dietary management of FPIES currently involves avoiding allergens, offering complementary foods to encourage normal growth and providing families with individualized feeding plans. The elimination diet does not promote healing, it only prevents adverse reactions from culprit food ingestion. Recovery (i.e. tolerance to the culprit food) is achieved spontaneously over time. However, for some children, tolerance does not occur. These patients suffer from persistent FPIES. For these patients oral immunotherapy (OIT) is not yet planned and randomized and controlled studies are needed to demonstrate its efficacy and safety. The primary objective of the study will be to verify, with a multicenter, prospective, randomized study, stratified for the main 4 offending foods in Italy (cows milk, hens egg, fish and cereals), open-label and with an adequate sample size, the efficacy and safety of an OIT procedure in children affected by acute persistent FPIES. The comparison will be made between a population of children affected by acute persistent FPIES subjected to OIT for the offending food (DOPA group) and a population of children affected by acute persistent FPIES subjected to the traditional measure, i.e. the elimination diet for the offending food (Diet group).

Efficacy will be measured through:

* Comparison of the percentages of children who have increased their reactivity threshold even to the point of no adverse reactions to the offending food following the intake of a normal dose for their age in the two populations during treatment;

* Comparison of the percentages of children who have reached tolerance towards the culprit food in the two populations;

Safety will be measured through:

- Comparison of the percentages of children who have presented adverse reactions following the ingestion (accidental in the Diet group and expected in the DOPA group) of the culprit food after enrollment in the study.

The definitions of desensitization and tolerance are taken from the EAACI 2018 guidelines on immunotherapy for IgE-mediated AA. In particular, desensitization corresponds to the absence of adverse reactions following the ingestion of the culprit food (in quantities up to a normal dose for age) during oral immunotherapy. This is a reversible or partially reversible clinical response that depends on continued exposure to the allergen. If the administration of the allergen is interrupted, the previous level of clinical reactivity may return. Tolerance corresponds to the absence of adverse reactions following the ingestion of the culprit food despite a period of absence of exposure.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Study First Posted: 2024-09-26
• Last Update Posted: 2024-09-26
• Study Start: 2024-10-01
• Primary Completion: 2027-10-01
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DOPA group	Oral immunotherapy (OIT)	Children affected by acute persistent FPIES subjected to OIT for the offending food
Diet group	Culprit food elimination diet	Children affected by acute persistent FPIES subjected to the traditional measure, i.e. the elimination diet for the offending food

Primary Outcome Measures

Name	Time	Method
Comparison of the percentages of participants who will achieve desensitization to the culprit food in the two populations	18 months	Efficacy will be measured through comparison of the percentages of children who will have increased their threshold of reactivity to the incriminated food following the intake of a normal dose for their age, in the two study populations (Definition of desensitization and tolerance according to EAACI 2018 guidelines on immunotherapy for IgE-mediated AA)

Secondary Outcome Measures

Name	Time	Method
Phenotypic characteristics of the patient who responds to OIT	18 months	Define the phenotypic characteristics of the patient with acute FPIES who will respond best to OIT

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Pediatria; 🇮🇹 Roma, Italy