{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T17:29:29Z","timestamp":1769880569709,"version":"3.49.0"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2013,5,24]],"date-time":"2013-05-24T00:00:00Z","timestamp":1369353600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Gastroenterol"],"published-print":{"date-parts":[[2013,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>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). <jats:italic>Triticum monococcum<\/jats:italic>, 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 <jats:italic>Tm<\/jats:italic> in patients with CD on GFD.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>We performed a single blind, cross-over study involving 12 CD patients who had been on a GFD for at least 12\u00a0months, 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\u2009\u00b1\u2009SD; paired t-test and \u03c7<jats:sup>2<\/jats:sup> test were used as appropriate.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>The urinary L\/R ratio did not change significantly upon challenge with the 3 cereals, and was 0.055\u2009\u00b1\u20090.026 for <jats:italic>Tm Vs<\/jats:italic> 0.058\u2009\u00b1\u20090.035 for rice (p\u2009=\u20090.6736) and Vs 0.063\u2009\u00b1\u20090.054 with Amygluten (p\u2009=\u20090.6071). Adverse gastrointestinal events were 8 for Tm, Vs 11 for rice (p\u2009=\u20090.6321) and Vs 31 for Amygluten p\u2009=\u20090.0016), and, in all cases events were graded as \u201cmild\u201d or \u201cmoderate\u201d with TM and rice, and as \u201csevere\u201d or \u201cdisabling\u201d in 4 cases during Amygluten.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>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. <jats:italic>Tm<\/jats:italic> was, however, well tolerated by all patients providing the rationale for further investigation on the safety of this cereal for CD patients.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Trial registration<\/jats:title>\n            <jats:p>EudraCT-AIFA <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2008-000697-20\/IT\" ext-link-type=\"uri\">n2008-000697-20<\/jats:ext-link>\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1186\/1471-230x-13-92","type":"journal-article","created":{"date-parts":[[2013,5,24]],"date-time":"2013-05-24T10:16:03Z","timestamp":1369390563000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":25,"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"],"prefix":"10.1186","volume":"13","author":[{"given":"Barbara","family":"Zanini","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beatrice","family":"Petroboni","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tarcisio","family":"Not","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicola","family":"Di Toro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vincenzo","family":"Villanacci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francesco","family":"Lanzarotto","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Norberto","family":"Pogna","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiara","family":"Ricci","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alberto","family":"Lanzini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2013,5,24]]},"reference":[{"key":"952_CR1","doi-asserted-by":"publisher","first-page":"2419","DOI":"10.1056\/NEJMcp1113994","volume":"367","author":"A Fasano","year":"2012","unstructured":"Fasano A, Catassi C: Clinical practice. 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