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
About this trial
This is an interventional treatment trial for Cow's Milk Allergy
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
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
NCT ID
NCT02081651
First Posted
February 27, 2014
Last Updated
March 5, 2014
Sponsor
Federico II University
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
Learn more about this trial
Parmigiano-Reggiano Cheese as a Possible Strategy to Acquire Oral Tolerance in Children With Cow's Milk Allergy
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