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

NCT ID: NCT03861910

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 365 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-12-31

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.

Conditions

Allergy Milk; Allergy;Food; Allergic Asthma; Allergic Conjunctivitis; Allergy Skin

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

extensively hydrolyzed casein formula+LGG

subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG as exclusion diet

hypoallergenic formulas

Intervention Type: DIETARY_SUPPLEMENT

hypoallergenic formulas used for cow milk allergy treatment

extensively hydrolyzed whey formula;

subjects with IgE mediated cow milk allergy treated with extensively hydrolyzed whey formula as exclusion diet

hypoallergenic formulas

Intervention Type: DIETARY_SUPPLEMENT

hypoallergenic formulas used for cow milk allergy treatment

hydrolyzed rice formula

subjects with IgE mediated cow milk allergy treated with hydrolyzed rice formula as exclusion diet

hypoallergenic formulas

Intervention Type: DIETARY_SUPPLEMENT

hypoallergenic formulas used for cow milk allergy treatment

soy based formula

subjects with IgE mediated cow milk allergy treated with soy based formula as exclusion diet

hypoallergenic formulas

Intervention Type: DIETARY_SUPPLEMENT

hypoallergenic formulas used for cow milk allergy treatment

amino-acid based formula

subjects with IgE mediated cow milk allergy treated with amino-acid based formula as exclusion diet

hypoallergenic formulas

Intervention Type: DIETARY_SUPPLEMENT

hypoallergenic formulas used for cow milk allergy treatment

Interventions

hypoallergenic formulas

hypoallergenic formulas used for cow milk allergy treatment

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani, MD, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Naples Federico II

Naples, , Italy

Countries

Italy

Other Identifiers

109n19

Identifier Type: -

Identifier Source: org_study_id