COW'S MILK ALLERGY Clinical Trial
— ImmuneBLGOfficial title:
Study of the Immunoreactivity of Native and Polymerized Beta-lactoglobulin in Children and Adults With Cow's Milk Allergy and/or Intolerance
Bovine β-lactoglobulin (Bos d 5) is an allergen from cow's milk with relevance to human health. We employed β-lactoglobulin polymerized using microbial transglutaminase as a model of study to identify whether protein polymerization could reduce in vivo allergenicity and maintain in vitro and ex vivo immunoreactivity for the purpose of producing a suitable molecule for use in tolerance-induction protocols. Based on previous protocols applied in mice and children, we performed in vivo challenges (using a skin prick test) with native and polymerized β-lactoglobulin in adult patients with an IgE-mediated allergy to Bos d 5. In vitro humoral immunoreactivity was analyzed using immunoblotting. Cell-mediated immunoreactivity was analyzed using ex vivo challenges with native and polymerized β-lactoglobulin monitored by leukocyte adherence inhibition tests. The study hypothesis is to identify a decrease on beta-lactoglobulin immunoreactivity after polymerization.
Status | Completed |
Enrollment | 114 |
Est. completion date | July 2011 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - The presence of clinical cow's milk allergy and specific IgE against beta-lactoglobulin Exclusion Criteria: - The absence of clinical cow's milk allergy and specific IgE against beta-lactoglobulin |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Brazil | University of Campinas | Campinas | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
Olivier CE, Villas-Boas MB, Netto FM, Zollner RL. Allergenicity of Bos d 5 in Children with Cow's Milk Allergy is Reduced by Transglutaminase Polymerization. Ped Allergy Immunol Pulmonol. 2012; 25(1)30-33.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of beta-lactoglobulin immunoreactivity after polymerization | The skin tests and ex vivo challenges are used to demonstrate if the polymerization can alter beta-lactoglobulin immunorreactivity. | two years | No |
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