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.
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Full eligibility criteria for NCT01589731
Ages eligible for Study
18 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
The presence of clinical cow's milk allergy and specific IgE against beta-lactoglobulin
The absence of clinical cow's milk allergy and specific IgE against beta-lactoglobulin
All locations for NCT01589731
University of Campinas
Campinas, Sao Paulo, Brazil, 13083-887
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Tris trial is registered with FDA with number: NCT01589731. The sponsor of the trial is University of Campinas, Brazil and it is looking for 114 volunteers for the current phase.
Official trial title: Study of the Immunoreactivity of Native and Polymerized Beta-lactoglobulin in Children and Adults With Cow's Milk Allergy and/or Intolerance
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