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

Barbara Zanini, Beatrice Petroboni, Tarcisio Not, Nicola Di Toro, Vincenzo Villanacci, Francesco Lanzarotto, Norberto Pogna, Chiara Ricci, Alberto Lanzini

Research output: Contribution to journalArticle

9 Citations (Scopus)

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.Trial registration: EudraCT-AIFA n2008-000697-20.

Original languageEnglish
Article number92
JournalBMC Gastroenterology
Volume13
Issue number1
DOIs
Publication statusPublished - May 24 2013

Fingerprint

Celiac Disease
Cross-Over Studies
Triticum
Gluten-Free Diet
Safety
Lactulose
Rhamnose
Glutens
Poisons
Proteins
Complementary Therapies
Permeability
High Pressure Liquid Chromatography
Edible Grain
Oryza

Keywords

  • Celiac disease
  • Intestinal permeability
  • Toxicity
  • Triticum monococcum

ASJC Scopus subject areas

  • Gastroenterology
  • Medicine(all)

Cite this

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. / Zanini, Barbara; Petroboni, Beatrice; Not, Tarcisio; Di Toro, Nicola; Villanacci, Vincenzo; Lanzarotto, Francesco; Pogna, Norberto; Ricci, Chiara; Lanzini, Alberto.

In: BMC Gastroenterology, Vol. 13, No. 1, 92, 24.05.2013.

Research output: Contribution to journalArticle

Zanini, Barbara ; Petroboni, Beatrice ; Not, Tarcisio ; Di Toro, Nicola ; Villanacci, Vincenzo ; Lanzarotto, Francesco ; Pogna, Norberto ; Ricci, Chiara ; Lanzini, Alberto. / 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. In: BMC Gastroenterology. 2013 ; Vol. 13, No. 1.
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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.Trial registration: EudraCT-AIFA n2008-000697-20.",
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AU - Petroboni, Beatrice

AU - Not, Tarcisio

AU - Di Toro, Nicola

AU - Villanacci, Vincenzo

AU - Lanzarotto, Francesco

AU - Pogna, Norberto

AU - Ricci, Chiara

AU - Lanzini, Alberto

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N2 - 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.Trial registration: EudraCT-AIFA n2008-000697-20.

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KW - Intestinal permeability

KW - Toxicity

KW - Triticum monococcum

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