Hypoallergenicity of a New Formula in Subjects With Cow's Milk Allergy — NIQA  

Allergy Clinical Trial

Official title: Hypoallergenicity of a New Extensively Hydrolyzed Casein-based Liquid Formula in Infants and Children With Cow's Milk Allergy (CMA): a Randomized Study

Status Recruiting

Clinical Trial Summary

Cow's milk protein allergy (CMA) is an immune-mediated reaction which can either be antibody-driven (IgE-mediated) or cell-mediated (non-IgE-mediated) or mixed, and elicits reactions which are reproducible upon re-exposure to cow's milk proteins. Estimates of CMA prevalence depend on the diagnosis procedure used; recently, a meta-analysis stated an overall pooled estimate for 0-1 year old infants of point prevalence of CMA reported by parents of 4.2% (95 % confidence interval (CI): 3.2-5.4), decreasing to 2.0% (1.5-2.5) when CMA was proven with a double-blind placebo-controlled food challenge (DBPCFC).

CMA manifests through diverse and non-specific symptoms, rendering the CMA diagnosis very difficult. CMA symptoms mainly concern the cutaneous area, the respiratory and gastrointestinal tracts but can also be general. The DBPCFC is therefore considered as the gold standard for the CMA diagnosis.

CMA management consists in the elimination of any source of non-hydrolyzed cow' milk protein from the diet, which is mainly achieved in children by using extensively hydrolyzed formulae (eHFs). As the molecular weight profile of a given hydrolysate cannot predict potential reaction in a given child, the American Academy of Pediatrics recommended that tolerance/hypoallergenicity of any formula intended for children with CMA should be clinically tested in that specific population.

The purpose of this study is to demonstrate the hypoallergenicity of a new liquid hydrolyzed casein-based formula (Investigational Formula) in the management of infants and children with CMA.

Clinical Trial Description

This study is a randomized, double-blind, controlled, crossover study that will be performed at a tertiary center for pediatric allergy: the Pediatric Allergy Program of the Department of Translational Medical Science of the University Federico II of Naples, Italy.

In this single-center study, the hypoallergenicity of an investigational extensively hydrolyzed (EH) cow milk protein formula in infants and children with CMA will be prospectively assessed through a doubleblind placebo-controlled food challenge (DBPCFC), with the placebo control and the investigational formula fed in a randomized order.

The design of the food challenges will be based on the approach used to diagnose food allergies: the DBPCFC. Although participants will not be exposed to any CMP in this study, and thus the concept of a "food challenge" does not apply, the general approach of a DBPCFC is still appropriate because it allows systematic, controlled, and standardized assessment of the hypoallergenicity of the Investigational Formula. The number of participants needed to project with 95% confidence (one-sided interval) that less than 10% of infants and children will react to the product is 29 consecutive participants if no clinical reactions are observed. A formula can be labelled hypoallergenic if infants with documented CMA do not react with defined symptoms to the formula under double-blind placebo controlled conditions as described above.

A 7-day home feeding period with the investigational formula will follow. Participants will be monitored for any indication of allergic or other types of adverse events throughout the study. ;

Related Conditions & MeSH terms

• Allergy
• Cow's Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

• NCT number: NCT06134466
• Study type: Interventional
• Source: Federico II University
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Completion date: December 31, 2025