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Completed

NCT Number: NCT03861910

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

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.

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Key information

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Naples Federico II

Naples, 80131, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

hypoallergenic formulas

Dietary Supplement

hypoallergenic formulas used for cow milk allergy treatment

Primary outcomes

  1. Rate of subjects with occurrence of other of allergic manifestations

    Time frame: 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 outcomes

  1. Rate of subjects with tolerance acquisition to cow's milk

    Time frame: 3 years

    To evaluate the tolerance acquisition to cow's milk

  2. Change in metagenomics and metabolomics

    Time frame: 3 years

    16S rRNA gene amplicon sequencing

  3. Epigenetic modifications in cytokines genes

    Time frame: 3 years

    Serum levels (pg/ml) of interleukin 4, interleukin 5, interleukin 10, interferon gamma, FOXP3 in children with cow's milk allergy

  4. Epigenetic modifications in cytokines genes

    Time frame: 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

  5. Rate of subjects with occurrence of other of allergic manifestations

    Time frame: 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

  6. Rate of subjects with tolerance acquisition to cow's milk

    Time frame: after 4 to 6 years follow-up

    To evaluate the tolerance acquisition to cow's milk

  7. Rate of subjects with any autoimmune disease

    Time frame: 6 years

    To evaluate the occurrence of type 1 diabetes, celiac disease, juvenile idiopathic arthritis, thyroiditis, inflammatory bowel diseases

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: ATMAII

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Mar 4, 2019
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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