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

Study Purpose

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.#46; 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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 1 Month - 12 Months
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Federico II University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Active, not recruiting
Countries Italy

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergy Milk, Allergy;Food, Allergic Asthma, Allergic Conjunctivitis, Allergy Skin
Arms & Interventions


: 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

: extensively hydrolyzed whey formula;

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

: hydrolyzed rice formula

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

: soy based formula

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

: amino-acid based formula

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


Dietary Supplement: - hypoallergenic formulas

hypoallergenic formulas used for cow milk allergy treatment

Contact a Trial Team

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International Sites

University of Naples Federico II, Naples, Italy



University of Naples Federico II

Naples, , 80131

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