Dietary Choice for the Management of Cow's Milk Allergy Influences Other Allergic Manifestations

Completed

• Conditions: Allergic Asthma; Allergic Conjunctivitis; Allergy Milk; Allergy;Food; Allergy Skin
• Interventions: Dietary Supplement: hypoallergenic formulas

• Registration Number: NCT03861910
• Lead Sponsor: Federico II University

Brief Summary

Food allergy is a common chronic condition in childhood. Recent studies have suggested that the natural history of food allergy has changed during the last two decades, with an increased prevalence, severity of clinical manifestations, and risk of persistence into later ages. The increased food allergy prevalence in children has an important economic impact, with significant direct costs for the healthcare system and even larger costs for the families of food-allergic patients. In addition, children with food allergies are at increased risk to develop other allergic manifestations later in life. According to a recent study, children with a food allergy are 2 to 4 times more likely to develop other atopic manifestations such as asthma (4.0 times), atopic eczema (2.4 times), and respiratory allergies (3.6 times), compared to children without a food allergy. Cow's milk allergy is among the most common food allergy in early childhood, with an estimated prevalence of 2% to 3%. It has been previously showed that in children with cow milk allergy, an extensively hydrolysed casein formula supplemented with the probiotic Lactobacillus rhamnosus GG induced higher tolerance rates compared to extensively hydrolysed casein formula without Lactobacillus rhamnosus GG and other formulas. These findings were consistent with those of a 1-year follow-up study performed in the US that showed better outcomes using an extensively hydrolysed casein formula+Lactobacillus rhamnosus GG vs. an extensively hydrolysed casein formula or amino acid-based formula for the first-line dietary management of cow milk allergy. In addition it has been recently demonstrated that extensively hydrolysed casein formula + Lactobacillus rhamnosus GG reduces the incidence of other atopic manifestations and hastens the development of oral tolerance in children with IgE-mediated cow milk allergy.

The present randomized controlled trial (RCT) was designed to test whether different dietary interventions could influence the occurrence of other atopic manifestations in children with IgE-mediated cow milk allergy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Primary Completion: 2020-05
• Study Completion: 2021-12
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

Inclusion Criteria

• age 1-12 months
• IgE-mediated CMA

Exclusion Criteria

• cow's milk protein-induced anaphylaxis,
• food protein induced enterocolitis syndrome,
• other food allergies,
• other allergic diseases,
• non-CMA-related atopic eczema,
• 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,
• administration of prebiotics or probiotics during the 4 weeks before enrolment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
hydrolyzed rice formula	hypoallergenic formulas	subjects with IgE mediated cow milk allergy treated with hydrolyzed rice formula as exclusion diet
soy based formula	hypoallergenic formulas	subjects with IgE mediated cow milk allergy treated with soy based formula as exclusion diet
extensively hydrolyzed whey formula;	hypoallergenic formulas	subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed whey formula as exclusion diet
extensively hydrolyzed casein formula+LGG	hypoallergenic formulas	subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG as exclusion diet
amino-acid based formula	hypoallergenic formulas	subjects with IgE mediated cow milk allergy treated with amino-acid based formula as exclusion diet

Primary Outcome Measures

Name	Time	Method
Rate of subjects with occurrence of other of allergic manifestations	3 years	To evaluate the effect of different dietary strategies on the occurrence of eczema, urticaria, asthma and rhinoconjunctivitis in children with IgE-mediated cow milk allergy

Secondary Outcome Measures

Name	Time	Method
Change in metagenomics and metabolomics	3 years	16S rRNA gene amplicon sequencing
Rate of subjects with tolerance acquisition to cow's milk	after 4 to 6 years follow-up	To evaluate the tolerance acquisition to cow's milk
Rate of subjects with occurrence of other of allergic manifestations	after 4 to 6 years follow-up	To evaluate the effect of different dietary strategies on the occurrence of eczema, urticaria, asthma and rhinoconjunctivitis in children with IgE-mediated cow milk allergy
Rate of subjects with any autoimmune disease	6 years	To evaluate the occurrence of type 1 diabetes, celiac disease, juvenile idiopathic arthritis, thyroiditis, inflammatory bowel diseases
Epigenetic modifications in cytokines genes	3 years	Methylation rate (%) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergyFOXP3 in children with cow's milk allergy

Trial Locations

Locations (1)

University of Naples Federico II; 🇮🇹 Naples, Italy