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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Federico II University
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University
ClinicalTrials.gov Identifier:
NCT02081651
First received: February 27, 2014
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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 .


Condition Intervention Phase
Cow's Milk Allergy
Dietary Supplement: Parmigiano Reggiano cheese
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Federico II University:

Primary Outcome Measures:
  • Rate of patients who acquire immunological tolerance to cow's milk [ Time Frame: After 12 months of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of patients with positive skin prick test with Parmigiano Reggiano cheese [ Time Frame: Enrollment and after 12 months of dietary treatment ] [ Designated as safety issue: No ]
  • Rate of patients able to tolerate the Parmigiano Reggiano cheese at enrollment [ Time Frame: Enrollment ] [ Designated as safety issue: No ]
  • Differences in level of faecal butyrate after 12 months od treatment [ Time Frame: After 12 months ]

Estimated Enrollment: 90
Study Start Date: March 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Parmigiano Reggiano cheese
Children treated Parmigiano Reggiano cheese for 12 months
Dietary Supplement: Parmigiano Reggiano cheese
No Intervention: Control subjects
Children with cow's milk allergy not assuming Parmigiano Reggiano cheese

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT02081651     History of Changes
Other Study ID Numbers: 272/13
Study First Received: February 27, 2014
Last Updated: March 5, 2014
Health Authority: Italy: Ethics Committee Carlo Romano

Additional relevant MeSH terms:
Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on October 19, 2014