Status:
COMPLETED
Safety of Prolonged Administration of Triticum Monococcum in Celiac Disease
Lead Sponsor:
Università degli Studi di Brescia
Conditions:
Celiac Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Preliminary studies on safety profile of Triticum Monococcum (Tm, a variety of Ancient Wheat) have provided conflicting results with some in vitro and ex vivo studies consistent with non toxicity and ...
Eligibility Criteria
Inclusion
- Adult Celiac patients on Gluten Free Diet (GFD) for at least one year
- Strict adherence to GFD
- Negative Celiac related serology
- Normal duodenal Histology defined as Marsh Class 0-II
- Willing to participate and adhere to study protocol
- Sign of the informed consent
Exclusion
- Pregnancy
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02220166
Start Date
November 1 2010
End Date
August 1 2011
Last Update
August 19 2014
Active Locations (1)
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1
AO Spedali Civili of Brescia
Brescia, Italy, I-25123