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

NCT06134466 | Completed

• 1 other identifier: 27/2023
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergy; Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

• Number of IgE-mediated cow's milk allergy subjects with negative of oral food challenge for the new investigational extensively casein formula

  Evaluation of the hypoallergenicity (negative oral food challenge) of an new investigational extensively casein formula in infants and children with IgE-mediated CMA

  Through study completion, an average up tp 50 days

Secondary Outcomes (1)

• adverse events

  Through study completion, an average up tp 50 days

Study Arms (1)

Liquid Formula

EXPERIMENTAL

Liquid Formula (Extensively hydrolyzed cow's milk protein infant formula) - 2.8 g protein/100 kcal

Dietary Supplement: Liquid Extensively hydrolyzed cow's milk protein infant formula

Interventions

Liquid Extensively hydrolyzed cow's milk protein infant formula DIETARY_SUPPLEMENT

Liquid Investigational Formula (Extensively hydrolyzed cow's milk protein infant formula) 2.8 g protein/100 kcal

Liquid Formula

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants and children between 6 and 36 months of age
• Gestational age ≥ 37 weeks
• Diagnosis of CMA confirmed through a DBPCFC performed within 3 months prior to the enrolment
• Stable clinical condition and free from any symptoms possibly related to CMA for at least four weeks prior to study enrollment
• Observing a strict cow's milk elimination diet for at least 4 weeks prior to study enrollment and until the completion of the study
• Parent(s) or legal guardian agrees not to enroll infant or child in another interventional clinical study while participating in this study
• Written informed consent obtained from at least one parent (or legally acceptable representative \[LAR\], if applicable)
• Infant or child's parent(s) / LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol

You may not qualify if:

• History of anaphylaxis to milk
• Infant is exclusively breastfed
• Any chronic diseases (except mild-moderate atopic eczema), chromosomal or major congenital anomalies (based on medical history and/or commonly performed diagnostic criteria).
• Major gastrointestinal disease/abnormalities (other than CMA).
• Other allergies.
• Immunodeficiency.
• Antihistamine use (excluding eye drops) within 7 days prior to the food challenge or oral steroid use within 14 days prior to the food challenge.
• Persistent wheeze or chronic respiratory disease.
• Severe uncontrolled eczema.
• Infant or child's parent has other medical or psychiatric condition that, in the judgement of the Investigator, would make the infant or child inappropriate for entry into the study.
• Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment.
• Use of systemic immunomodulatory treatment

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Hypersensitivity; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 18, 2023
• Study Start: February 13, 2024
• Primary Completion: July 22, 2024
• Study Completion: July 22, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

IT (1)