PHASE II TRIAL TO EVALUATE EFFICACY AND SECURITY OF ACUTE INTAKE OF GLUTEN DERIVED FROM TRITICUM MONOCOCCUM IN PATIENTS AFFECTED BY CELIAC DISEASE: THE "ANCIENT WHEAT" PROJECT

Registry ID
EUCTR2008-000697-20
Source registry
EUCTR
Status
Completed
Phase
PHASE2
Sponsor
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Start date
2008-04-15
Last update
2026-08-16

Conditions

Summary

Primary objective of the study is to evaluate the efficacy of acute intake of a small amount of flour derived from Triticum monococcum (a variety of ancient wheat) in patients with celiac disease, in gluten free diet. A small amount of toxic gluten (2.5 milligrams) can modify intestinal permeability in celiac patients, so this parameter can be a good indicator to verify if gluten from Triticum monococcum can be considered a non toxic gluten and to test the hypothesis of its introduction in a gluten free diet.

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