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

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ClinicalTrials.gov Identifier: NCT03861910
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

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.


Condition or disease Intervention/treatment
Allergy Milk Allergy;Food Allergic Asthma Allergic Conjunctivitis Allergy Skin Dietary Supplement: hypoallergenic formulas

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Study Type : Observational
Estimated Enrollment : 365 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
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
Dietary Supplement: hypoallergenic formulas
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
Dietary Supplement: hypoallergenic formulas
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
Dietary Supplement: hypoallergenic formulas
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
Dietary Supplement: hypoallergenic formulas
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
Dietary Supplement: hypoallergenic formulas
hypoallergenic formulas used for cow milk allergy treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Children who were consecutively observed at a FP office because the recent occurrence of signs and symptoms possibly related to IgE-mediated CMA were sent to our tertiary centre for paediatric allergy for possible inclusion in the study. Only subjects who met the inclusion criteria will be invited to participate to the study.Written informed consent will be obtained from the parents of each subject. Anamnestic, demographic, anthropometric and clinical data, as well as information on socio-demographic factors, family and living conditions, parental history of allergic diseases, maternal smoking during pregnancy, environmental tobacco smoke exposure, number of siblings, and pet ownership were obtained from the parents and recorded in a clinical database. For children with sure diagnosis of IgE-mediated CMA during a 3-year follow-up,3 visits every 12 months will be performed. Stool samples for metagenomics and metabolomics and blood sample for epigenetics studies will be collected.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03861910


Locations
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Italy
University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani    0817462680      
Sponsors and Collaborators
Federico II University

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Responsible Party: Roberto Berni Canani, Associate Professor, Federico II University
ClinicalTrials.gov Identifier: NCT03861910    
Other Study ID Numbers: 109n19
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Food Hypersensitivity