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

Allergic Conjunctivitis Clinical Trial

— ATMAII  

Official title:

Dietary Choice for the Management of Cow's Milk Allergy Influences the Acquisition of Oral Tolerance and the Occurrence of Other Allergic Manifestations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861910
• Other study ID #: 109n19
• Status: Completed
• Start date: December 2014
• Est. completion date: December 2021

Study information

• Verified date: August 2023
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: December 2021
• Est. primary completion date: May 2020
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Conjunctivitis
• Allergy Milk
• Allergy Skin
• Allergy;Food
• Conjunctivitis
• Conjunctivitis, Allergic
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• hypoallergenic formulas
hypoallergenic formulas used for cow milk allergy treatment

Locations

Country	Name	City	State
Italy	University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of subjects with occurrence of other of allergic manifestations	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	3 years
Secondary	Rate of subjects with tolerance acquisition to cow's milk	To evaluate the tolerance acquisition to cow's milk	3 years
Secondary	Change in metagenomics and metabolomics	16S rRNA gene amplicon sequencing	3 years
Secondary	Epigenetic modifications in cytokines genes	Serum levels (pg/ml) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergy	3 years
Secondary	Epigenetic modifications in cytokines genes	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	3 years
Secondary	Rate of subjects with occurrence of other of allergic manifestations	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	after 4 to 6 years follow-up
Secondary	Rate of subjects with tolerance acquisition to cow's milk	To evaluate the tolerance acquisition to cow's milk	after 4 to 6 years follow-up
Secondary	Rate of subjects with any autoimmune disease	To evaluate the occurrence of diabetes, celiac disease and thyroiditis	6 years