title: Search for atoxic cereals: a single blind, cross-over study on the safety of a single dose of Triticum monococcum, in patients with celiac disease.
abstract: BACKGROUND
  Cereals of baking quality with absent or reduced toxicity are actively sought as alternative therapy to a gluten-free diet (GFD) for patients with coeliac disease (CD). Triticum monococcum, an ancient wheat, is a potential candidate having no toxicity in in-vitro and ex-vivo studies. The aim of our study was to investigate on the safety of administration of a single dose of gluten of Tm in patients with CD on GFD.
  
  
  METHODS
  We performed a single blind, cross-over study involving 12 CD patients who had been on a GFD for at least 12 months, challenged on day 0, 14 and 28 with a single fixed dose of 2.5 grams of the following (random order): Tm, rice (as reference atoxic protein) and Amygluten (as reference toxic protein) dispersed in a gluten-free pudding. The primary end-point of the study was the change in intestinal permeability, as assessed by changes in the urinary lactulose/rhamnose ratio (L/R ratio) measured by High Pressure Liquid Chromatography. We also assessed the occurrence of adverse gastrointestinal events, graded for intensity and duration according to the WHO scale. Variables were expressed as mean ± SD; paired t-test and χ² test were used as appropriate.
  
  
  RESULTS
  The urinary L/R ratio did not change significantly upon challenge with the 3 cereals, and was 0.055 ± 0.026 for Tm Vs 0.058 ± 0.035 for rice (p = 0.6736) and Vs 0.063 ± 0.054 with Amygluten (p = 0.6071). Adverse gastrointestinal events were 8 for Tm, Vs 11 for rice (p = 0.6321) and Vs 31 for Amygluten p = 0.0016), and, in all cases events were graded as "mild" or "moderate" with TM and rice, and as "severe" or "disabling" in 4 cases during Amygluten.
  
  
  CONCLUSIONS
  No definite conclusion can be drawn on the safety of Tm, based on no change in urinary L/R because even Amygluten, a toxic wheat protein, did not cause a significant change in urinary L/R indicating low sensitivity of this methodology in studies on acute toxicity. Tm was, however, well tolerated by all patients providing the rationale for further investigation on the safety of this cereal for CD patients.
  
  
  BACKGROUND
  EudraCT-AIFA n2008-000697-20.
authors.forename: Barbara
authors.initials: B
authors.lastname: Zanini
authors.forename: Beatrice
authors.initials: B
authors.lastname: Petroboni
authors.forename: Tarcisio
authors.initials: T
authors.lastname: Not
authors.forename: Nicola
authors.initials: N
authors.lastname: Di Toro
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Villanacci
authors.forename: Francesco
authors.initials: F
authors.lastname: Lanzarotto
authors.forename: Norberto
authors.initials: N
authors.lastname: Pogna
authors.forename: Chiara
authors.initials: C
authors.lastname: Ricci
authors.forename: Alberto
authors.initials: A
authors.lastname: Lanzini
mesh_terms: D002446:Celiac Disease / Q000178:diet therapy* / Q000378:metabolism; D018592:Cross-Over Studies; D055050:Diet, Gluten-Free; D002523:Edible Grain / Q000009:adverse effects; D005983:Glutens / Q000008:administration & dosage; D006801:Humans; D007408:Intestinal Absorption; D007792:Lactulose / Q000652:urine; D012275:Oryza; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D012210:Rhamnose / Q000652:urine; D016037:Single-Blind Method; D014908:Triticum
chemical_list: D010936:Plant Extracts; D007792:Lactulose; D005983:Glutens; D012210:Rhamnose