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

Sponsor
Federico II University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03861910
Collaborator
(none)
365
1
84
4.3

Study Details

Study Description

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 Phase
  • Dietary Supplement: hypoallergenic formulas

Study Design

Study Type:
Observational
Actual 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 :
Dec 1, 2014
Actual Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Rate of subjects with tolerance acquisition to cow's milk [3 years]

    To evaluate the tolerance acquisition to cow's milk

  2. Change in metagenomics and metabolomics [3 years]

    16S rRNA gene amplicon sequencing

  3. 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

  4. Epigenetic modifications in cytokines genes [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Month to 12 Months
Sexes Eligible for Study:
All
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Naples Federico II Naples Italy 80131

Sponsors and Collaborators

  • Federico II University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Roberto Berni Canani, Associate Professor, Federico II University
ClinicalTrials.gov Identifier:
NCT03861910
Other Study ID Numbers:
  • 109n19
First Posted:
Mar 4, 2019
Last Update Posted:
Sep 23, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2020