Allergic Asthma, Allergic Conjunctivitis, Allergy;Food, Allergy Milk, Allergy Skin
Conditions
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.
Interventions
DIETARY_SUPPLEMENThypoallergenic formulas
hypoallergenic formulas used for cow milk allergy treatment
Sponsors
Federico II University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of subjects with tolerance acquisition to cow's milk | 3 years | To evaluate the tolerance acquisition to cow's milk |
| Change in metagenomics and metabolomics | 3 years | 16S rRNA gene amplicon sequencing |
| Epigenetic modifications in cytokines genes | 3 years | Serum levels (pg/ml) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergy |
| 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 |
Countries
Italy
Outcome results
None listed