Clinical Trials Logo

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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Completed NCT01842711 - Cumulative Irritation Patch Test N/A
Completed NCT01633840 - New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges N/A
Completed NCT00554983 - Efficacy and Safety From a Recombinant Folding Variant of Bet v 1 Phase 3
Completed NCT00997971 - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein Phase 3
Completed NCT00331929 - Respiratory Health Study of Children in Kiryat Tivon N/A
Completed NCT00232518 - Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis N/A
Completed NCT00220753 - Air Cleaners for Children and Adolescents With Asthma and Dog Allergy N/A
Completed NCT04046731 - Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation N/A
Completed NCT04126096 - Negative Predictive Value and NIC of Beta-Lactam Antibiotics. N/A
Completed NCT04004351 - Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT04186949 - Early Origins of Allergy and Asthma
Completed NCT02127801 - Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants Phase 1
Enrolling by invitation NCT05011071 - The Alberta BLOOM Premature Child Study
Not yet recruiting NCT06330974 - Allergy, Asthma, and Atopic Eczema in Finland
Completed NCT02596321 - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma Phase 3
Terminated NCT02601690 - Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America
Completed NCT02306473 - The Leaky Lung Test Early Phase 1