Celiac disease MedDRA version: 9.1 Level: LLT Classification code 10007865 Term: Celiac sprue
Conditions
Interventions
Product Name: Triticum monococcum gluten
Pharmaceutical Form: Oral powder
INN or Proposed INN: Triticum monococcum gluten
Concentration unit: g gram(s)
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Secondary objective of the study is to test the safety of flour derived from Triticum monococcum in such patients, in terms of number of adverse events gastrointestinal or not, related to celiac disease or not, after the acute oral intake of a small amount of flour derived from Triticum monococcum.;Primary end point(s): To evaluate intestinal permeability we will evaluate the Lattulosio/Mannitolo ratio (L/M ratio) in urine after standard oral intake of the two sugars. We choosed High Pressure Liquid Cromatography, HPLC, to test L/M ratio in urine. | — |
Countries
Italy
Outcome results
None listed