Celiac Disease Clinical Trial
Official title:
Wheat Flour Subjected to Microbial Transglutaminase Enzymatic Treatment in the Presence of Lysine Ethyl Ester for Alimentary Use in the Treatment of Celiac Disease.
Celiac disease is one of the most common forms of food intolerance (prevalence 1/200). The
disease occurs in genetically predisposed individuals after ingestion of foods containing
gluten. Celiac patients can suffer from severe malabsorption syndrome, mainly characterized
by diarrhea and weight loss. The only therapeutic approach currently recognized is a
life-long gluten-free diet.
Specific regions of gluten molecule become recognizable by lymphocytes and activate them,
due to changes made by tissue transglutaminase. These changes consist in the conversion of
specific residues of glutamine into glutamic acid. The consequence is an increased binding
affinity between gluten and histocompatibility molecule (HLA-DQ2), localized on the surface
of the "antigen presenting cells" (APC); the exposure of the fragments of modified gluten on
the surface of APC is a phenomenon that eventually activates T lymphocytes.
Recent studies on modified gluten confirmed the hypothesis that it is possible to block the
presentation of gluten to lymphocytes by means of lysine ethyl ester binding exclusively to
those gluten regions responsible for lymphocyte activation.
The enzymatic treatment is performed directly on flour instead of extracted gluten,
maintaining the same anti-inflammatory effectiveness.
The procedure uses a food-grade enzyme, the microbial transglutaminase (mTGasi) isolated
from Streptoverticillium mobarensis, able to catalyze the formation of intermolecular
"cross-links" that modify the functional properties of the products.
Objective of the study is to validate the ability of the enzyme treatment of wheat flour
with mTGasi and lysine ethyl ester to block the toxic effect of gluten in celiac patients.
Celiac disease is one of the most common forms of food intolerance (prevalence 1/200). The
disease occurs in genetically predisposed individuals after ingestion of foods containing
wheat gluten and similar proteins found in other common cereals such as barley and rye.
Celiac patients can suffer from severe malabsorption syndrome, mainly characterized by
diarrhea, weight loss and growth retardation. The only therapeutic approach currently
recognized is a life-long gluten-free diet.
Specific regions of gluten molecule become recognizable by lymphocytes and activate them,
due to changes made by tissue transglutaminase. These changes consist in the conversion of
specific residues of glutamine (Q) into glutamic acid (E). The consequence is an increased
binding affinity between gluten and histocompatibility molecule (HLA-DQ2), localized on the
surface of the "antigen presenting cells" (APC); the exposure of the fragments of modified
gluten on the surface of APC is a phenomenon that eventually activates T lymphocytes.
Recent studies on modified gluten confirmed the hypothesis that it is possible to block the
presentation of gluten to lymphocytes by means of lysine ethyl ester binding exclusively to
those gluten regions responsible for lymphocyte activation.
Specifically, it is possible to perform the enzymatic treatment directly on flour instead of
extracted gluten, maintaining the same anti-inflammatory effectiveness. The final procedure
consists in dissolving the flour in water in the presence of appropriate concentrations of
enzyme and lysine ethyl ester, maintaining the suspension in constant motion for two hours
at room temperature.
The procedure uses a food-grade enzyme, the microbial transglutaminase (mTGasi) isolated
from Streptoverticillium mobarensis, already used for the preparation of food. The mTgasi is
able to catalyze the formation of intermolecular "cross-links" modifying the functional
properties of the products through the aggregation and polymerization of proteins. The
peculiar method identified by our laboratory reduces the possibility of cross-links between
proteins: consequently, minimal changes involve the gluten structure and, consequently, the
visco-elastic properties of the dough.
Objective of the study is to validate the ability of the enzyme treatment of wheat flour
with mTGasi and lysine ethyl ester to block the toxic effect of gluten in celiac patients.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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