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Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy

Primary Purpose

Cow's Milk Allergy

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Parmigiano Reggiano cheese
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow's Milk Allergy

Eligibility Criteria

3 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Children aged 3-10 years with cow's milk allergy

Exclusion Criteria:

  • children aged less than 3 years or aged more than 10 years,
  • concomitant chronic systemic diseases,
  • active tubercolosis,
  • autoimmune diseases,
  • immunodeficiency,
  • chronic inflammatory bowel disease,
  • celiac disease,
  • cystic fibrosis,
  • metabolic diseases,
  • malignancy,
  • malformations of the gastrointestinal tract,
  • suspected eosinophilic esophagitis or eosinophilic enterocolitis,
  • suspected food-protien-induced enterocolitis syndrome,
  • recent reaction to Parmigiano Reggiano cheese,
  • pre/probiotic assumption

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Parmigiano Reggiano cheese

    Control subjects

    Arm Description

    Children treated Parmigiano Reggiano cheese for 12 months

    Children with cow's milk allergy not assuming Parmigiano Reggiano cheese

    Outcomes

    Primary Outcome Measures

    Rate of patients who acquire immunological tolerance to cow's milk

    Secondary Outcome Measures

    Rate of patients with positive skin prick test with Parmigiano Reggiano cheese
    Rate of patients able to tolerate the Parmigiano Reggiano cheese at enrollment
    Differences in level of faecal butyrate after 12 months od treatment

    Full Information

    First Posted
    February 27, 2014
    Last Updated
    March 5, 2014
    Sponsor
    Federico II University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02081651
    Brief Title
    Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy
    Official Title
    Parmigiano-Reggiano Cheese as a Possible Strategy of Immunonutrition Able to Stimulate the Acquisition of Oral Tolerance in Childre With Cow's Milk Allergy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federico II University

    4. Oversight

    5. Study Description

    Brief Summary
    Cow's milk allergy is the most common food allergy in children. The scenery clinical and epidemiological of cow's milk allergy is significantly changed in the last decade. The severity of the clinical manifestations is still rising, and now cow's milk allergy has become the leading cause of hospitalization for food -induced anaphylaxis in our country. In addition, the overall prevalence of cow's milk allergy is increasing for a gradual reduction in the ability to acquire immunological tolerance to cow's milk protein in the first years of life. These mutations dictate the need to identify strategies to stimulate the acquisition of immunological tolerance in children affected by cow's milk allergy . The mechanisms of acquired immunological tolerance are not yet fully defined . The current view suggests the existence of a dynamic mechanism , consisting of various cellular compartments , which is set in a crucial environmental factors arising mainly from the diet and its effects on the intestinal microbiota. These acquisitions have contributed to the definition of a new concept in the field of human nutrition: immunonutrition. The immunonutrition is the ability, through the intake of specific nutrients on the immune system to interfere directly or indirectly through modulation of the composition and function of the intestinal microbiota. The proponent group has recently shown that it is possible to stimulate a more rapid acquisition of immunological tolerance in children affected by CMA through the administration of extensively hydrolysed casein containing the probiotic Lactobacillus rhamnosus GG (LGG) (Berni Canani et al. J Pediatr 2013) . Several lines of evidence suggest that this effect is induced by a combination of direct immunomodulatory action exerted by some small peptides derived from the beta - casein and the action of lactobacillus GG. It 's well known that the Lactobacillus GG is able to adjust the composition and functions of the microbiota in the child with CMA and directly adjust some immunological mechanisms involved in the pathogenesis of this condition. At the same time other groups have demonstrated the possibility that a high percentage of patients with IgE-mediated CMA is able to tolerate foods containing hydrolyzed cow's milk proteins with different processes. It has also been speculated that these strategies can facilitate the acquisition of immune tolerance in patients with cow's milk allergy. One of these foods is Parmigiano -Reggiano cheese, which is characterized by an ' extensive hydrolysis of the proteins in cow's milk , which degrade the caseins present and generate large amounts of peptides and free amino acids and by the presence of appreciable quantities of Lactobacillus GG in the samples to maturing higher . In a recent study it was shown that 58% of patients suffering from IgE-mediated CMA is able to tolerate a daily intake of normal amounts of this food , especially in the absence of a sensibilization to IgE specific to the beta lactoglobulin. These new findings allow us to hypothesize the use of Parmigiano REggiano cheese as a possible strategy immunonutrition can stimulate the acquisition of immune tolerance in patients with CMA .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cow's Milk Allergy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Parmigiano Reggiano cheese
    Arm Type
    Experimental
    Arm Description
    Children treated Parmigiano Reggiano cheese for 12 months
    Arm Title
    Control subjects
    Arm Type
    No Intervention
    Arm Description
    Children with cow's milk allergy not assuming Parmigiano Reggiano cheese
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Parmigiano Reggiano cheese
    Primary Outcome Measure Information:
    Title
    Rate of patients who acquire immunological tolerance to cow's milk
    Time Frame
    After 12 months of intervention
    Secondary Outcome Measure Information:
    Title
    Rate of patients with positive skin prick test with Parmigiano Reggiano cheese
    Time Frame
    Enrollment and after 12 months of dietary treatment
    Title
    Rate of patients able to tolerate the Parmigiano Reggiano cheese at enrollment
    Time Frame
    Enrollment
    Title
    Differences in level of faecal butyrate after 12 months od treatment
    Time Frame
    After 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Children aged 3-10 years with cow's milk allergy Exclusion Criteria: children aged less than 3 years or aged more than 10 years, concomitant chronic systemic diseases, active tubercolosis, autoimmune diseases, immunodeficiency, chronic inflammatory bowel disease, celiac disease, cystic fibrosis, metabolic diseases, malignancy, malformations of the gastrointestinal tract, suspected eosinophilic esophagitis or eosinophilic enterocolitis, suspected food-protien-induced enterocolitis syndrome, recent reaction to Parmigiano Reggiano cheese, pre/probiotic assumption

    12. IPD Sharing Statement

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    Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy

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