Tolerability of Hypoallergenic Formula in Children With Cow's Milk Allergy (SINEALLII)

Tolerability of the New Hypoallergenic Formula in Children With IgE Mediated Cow's Milk Allergy

Cow's milk protein allergy is defined as an immunological reaction to one or more milk proteins. A variety of symptoms can be suggestive for cow's milk protein allergy . Cow's milk protein allergy is suspected clinically in 5-15% of infants, while most estimates of prevalence of cow's milk protein allergy vary from only 2 to 5 %. Confusion regarding cow's milk protein allergy prevalence is often due to differences in study populations, study design and a lack of defined diagnostic criteria. The importance of defined diagnostic criteria needs to be emphasised. It precludes infants from an unnecessary diet and avoids delay in diagnosis, which can lead to malnutrition. The treatment of cow's milk protein allergy is the dietary elimination of cow's milk proteins. In non-breastfed infants and children less than 2 years of age, a substitute formula is mandatory as prescribed by several international scientific societies. Extensively hydrolyzed formulas are used as therapeutic formulas. An extensively hydrolysed formula is often a whey or casein based formula in which the protein has been chopped up in smaller pieces that are less allergenic. Because of high cross-reactivity (up to 80%) and nutritional inadequacy, the use of any other animal milk or soy-based formula is precluded.The infant should be maintained on an elimination diet until the child is between 9-12 months of age or at least for 6 months, whichever occurs first. In most cases, symptoms will improve substantially within 2-4 weeks if diagnosis is correct. According to consensus in literature, a therapeutic formula is a formula tolerated by at least 90% (with 95% confidence) of cow's milk protein allergy infants. The primary study outcome will be the evaluation of the hypoallergenicity of a new aminoacid based formula in children with confirmed immunoglobulin (Ig)E- mediated CMA. According to the American Academy of Pediatrics (AAP) Subcommittee on Nutrition and Allergic Diseases a hypoallergenic formula must be tested in infants and children with hypersensitivity to cow's milk proteins, with findings verified by elimination-challenge tests under double-blind, placebo-controlled conditions (DBPCFC).

Study Overview

• Status: Completed
• Conditions: Allergy Milk
• Intervention / Treatment: Dietary supplement: amino acid based formula

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Napoli
    • Portici, Napoli, Italy, 80055
      • Rita Nocerino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Consecutive patients aged 1-36 months with diagnosis of Immunoglobulin E-mediated cow milk allergy in the last 12 weeks,
• full and stable remission of allergy symptoms
• Written informed consent form collected by the parents.

Exclusion Criteria:

• Infant aged <1 months and >36 months,
• breast fed infants,
• other food allergies,
• other allergic diseases,
• evidence of non-IgE-mediated CMA,
• history of severe anaphylactic reaction,
• eosinophilic disorders of the gastrointestinal tract,
• chronic systemic diseases,
• congenital cardiac defects,
• active tuberculosis,
• autoimmune diseases,
• immunodeficiency,
• chronic inflammatory bowel diseases,
• celiac disease,
• cystic fibrosis,
• metabolic diseases,
• malignancy,
• chronic pulmonary diseases,
• malformations of the gastrointestinal and/or respiratory tract,
• use of systemic antibiotics or anti-mycotic drugs during 4 weeks before study entry;
• investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
• participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: amino acid based formula	Dietary supplement: amino acid based formula; amino acid based formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects tolerants to a new hypoallergenic formula demonstrated by oral food challenge with the new study formula	All subjects perform an oral food challenge with the new study formula. If the infant not react to the new hypoallergenic formula during the oral food challenge, the subjects tolerate this product.	After one week from the oral food challenge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of body weight in children assuming amino acid based formula	In the absence of reaction to the new amino acid based formula, a subgroup of child (n=15) will continue the second part of the study, with an open-label feeding with amino acid based formula for 180 days.	after 180 days

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Nocerino R, Di Scala C, Coppola S, Giglio V, Carucci L, Cosenza L, Voto L, Iannicelli AM, Luzzetti A, Berni Canani R. Tolerability of a new amino acid-based formula for children with IgE-mediated cow's milk allergy. Ital J Pediatr. 2021 Jul 3;47(1):151. doi: 10.1186/s13052-021-01096-3.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: April 5, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: 440/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No