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 - ANCIENT WHEAT

• Conditions: Celiac disease; MedDRA version: 9.1Level: LLTClassification code 10007865Term: Celiac sprue

• Registration Number: EUCTR2008-000697-20-IT
• Lead Sponsor: AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Males and females over 18 years of age;
Diagnosis of Celiac Disease proven by serologic test (positivity for Anti Tissue Transglutaminases) and confirmed by duodenal biopsy, Marsch score I or II;
HLA phenotypes DQ2 or DQ8;
Celiac disease in remission due to gluten free diet, started at least one year before enrolment, proven by serologic test (negativity for Anti Tissue Transglutaminases) and by clinical features (absence of disease symptons);
Willingness to avoid conceptions during the study;
Willingness to give written informed consent and willingness to participate and comply with the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Celiac disease with Marsh score IIIa or IIIb or IIIc;
Pregnancy or breast feeding;
Inborn selective deficit of IgA;
Diagnosis of diabetes mellitus Type I;
Down?s or Turner?s syndrome;
Diagnosis of any other alimentary intolerance;
History or evidence of severe clinical condition in sperimentator?s opinion (cancer, cirrhosis, respiratory or cardiac failure, chronic and progressive disease?);
Chronic therapies with any of the following drugs: protonic pump inhibitors, oral cts, pancreatic enzymes, fibrates, NSIDs, amphetamines;
Medical history of gastrointestinal disorders like diarrhoea, abdominal pain, vomiting;
Smoke habit (more than two cigarettes per day);
Active dependence for illicit drugs or alcohol;
Test positivity for HCVAb, HBsAg, HIVAb

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified